41 Food Safety jobs in Pittsburgh

• Responsible for administration of Manufacturing Quality Assurance and Compliance to assure timely delivery of results to manage the company objectives and production as well as new product introduction on time. Reviews procedures of quality systems, validation, change control, manufacturing discrepancy investigations, cGMP/regulatory compliance, and product specifications. Oversees responsibility for the coordination/approval of Periodic Quality Reports (PQRs). Leads regulatory quality inspections of the facility. Assumes responsibility for major projects assigned by Manager.
• Works independently of direct supervision but interacts with all levels within the site organization on a daily basis. Interacts regularly with Regulatory Affairs, Sales, Quality Assurance and Operations, Global Quality Management, and personnel. Routinely interacts with Regulatory Agencies including, but not limited to, FDA and DEA.
• Quality decision authority to Stop production and testing activities and contain materials and productions with immediate effect where critical deviations from regulatory requirements and/or Fresenius Kabi Quality Management System are noted.
• Directly manages the Quality department and performance of local quality systems including document control, training, CAPA, Supplier Controls Internal and External Audits, MQA/Batch Release, and Quality Control.
• Immediate notification to management on confirmed, reportable quality defects that become known from deviations, complaints, and other events and when notification to concerned Competent Authorities is required.
• Immediate notification to management on data integrity issues that become known.
• Regularly assess the quality management system, via internal audits and other applicable monitoring methods.
• Report to top management regarding the compliance and effectiveness of the quality management system.
• Directs investigations of product complaints for manufactured products and completion of appropriate documentation. Provides technical details as required in a manner consistent with the confidential and proprietary nature of the information. Interacts with the Medical Affairs and Vigilance Departments as needed.
• Participates in Regulatory/FDA inspections by providing information or expediting/obtaining information required by the inspectors. Schedules and conducts pre-inspection review of operations and follow-ups where corrective action is required. Facilitate external agency audits, inspections, and visits relative to the quality management system, including audit findings, responses, and corrective and preventative actions, as delegated.
• Ensure the promotion of awareness of customer requirements and regulatory requirements throughout the organization.
• Collection and reporting of Quality KPIs.
• Assurance that all products are released at the site, compliant with the quality management system, registration and GMP requirements.
• Support investigation of incoming complaints.
• Fosters an open environment of continuous improvement that drives quality employee engagement and meets pragmatic business needs.
• Coaches and provides critical quality thinking, mentoring, and appropriate escalation.
• Influences effective compliance-based decisions with cross functional communication and team building skills.
• Interacts with other Quality Units within the division and larger company.
• Ensures adequate training is provided and complete for employees in their respective function.
• Responsible for ensuring the Quality Management System requirements are met under ISO 9001 standards

REQUIREMENTS

• Bachelor's degree in Engineering or a related field,
• 10 years of previous Quality experience with 5 years in a leadership position
• Computer technical hardware/Software knowledge is a plus
• Knowledge of appropriate FDA, ISO, and global regulations regarding quality systems.
• The ability to effectively communicate with a broad spectrum of people having varying backgrounds, education, and experience.
• Experience dealing directly with FDA and notified bodies required.
• Strong, practical, and pragmatic knowledge of both US and global Quality system requirements and medical device/ biologics production.
• Must have the ability to act as a change agent and drive/influence change as well as effectively lead and motivate team members to achieve goals.

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability,401K with company contribution, andwellness program.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.

CMS

At ZOLL, we're passionate about improving patient outcomes and helping save lives. We provide innovative technologies that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide to diagnose and treat patients suffering from serious cardiopulmonary and respiratory conditions.

ZOLL Cardiac Management Solutions offers a unique portfolio of novel technologies designed to deliver better insights and better outcomes. On any given day, clinicians utilize these ZOLL products for tens of thousands of cardiac patients around the world:

• LifeVest, the world first wearable defibrillator, has been trusted to protect more than 1M patients at risk of sudden cardiac death.
• HFMS (Heart Failure Management system) is a non-invasive, patch-based device that monitors pulmonary fluid levels and has been shown to reduce heart failure readmissions rates by 38 percent.
• TherOx Super Saturated Oxygen (SSO2) Therapy is the first FDA-approved therapy since the stent 20+ years ago to reduce infarct size in patients with the most severe heart attacks.

• Performs internal quality audits and effectiveness reviews (FDA's QSR, ISO 13485, MDD, CMDR) Conducts supplier evaluations and audits
• Responsible for the development and execution of Lean/six-Sigma and other cost improvement initiatives that can be related to product quality
• Responsible to understand the appropriate legal and regulatory requirements in the areas of medical device operations and to establish robust processes and controls to ensure compliance
• Responsible to build and improve key business relationships within the organization's cross functional departments
• Ensure operations quality measurement systems are capable (Gauge R&R), process capability (Cpk) is high and process controls are in place to assure that products meet specifications
• Ensure that equipment is calibrated and maintained in accordance with requirements, and that these activities are properly documented
• Conducts various risk analysis activities for new and existing products including FMEAs and Fault Tree Analyses
• Prepare, submit and coordinate the process validation requirements for non-product software validations
• Participates in the FDA premarket approval process (PMA) for new and modified medical devices
• Participates in the nonconforming material/Material Review Board process Championing the implementation of Lean Manufacturing processes
• Participate in Kaizen events as a representative of the quality department

• Bachelor's Degree Requires a BS degree or equivalent experience in a technical or scientific discipline. required
• Experience in an FDA regulated Class III electrical medical device manufacturing environment preferred.
  preferred and
• Experienced in process development and validation for electro-mechanical assembly, test, and service.
  required and
• Formal Project management experience a plus preferred and
• Lean experience preferred and
• Experience with database queries and reporting in SQL or Microsoft Access preferred
• Six Sigma Green Belt Certification Preferred or
• Black Belt Preferred

• Understands and has applied in practice the concepts of process capability, process control, and measurement system capability.

• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• While performing the duties of this Job, the employee is regularly required to sit and talk or hear. The employee is occasionally required to stand; walk and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds.

• The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• The noise level in the work environment is usually quiet.

At PNC, our people are our greatest differentiator and competitive advantage in the markets we serve. We are all united in delivering the best experience for our customers. We work together each day to foster an inclusive workplace culture where all our employees feel respected, valued and have an opportunity to contribute to the company's success. As a Quality Assurance Lead within PNC's Legal Tech organization, you will be based in Pittsburgh, PA. The position is primarily based in a PNC location. Responsibilities require time in the office or in the field on a regular basis. Some responsibilities may be performed remotely, at the manager's discretion. "PNC will not provide sponsorship for employment visas or participate in STEM OPT for this position."

Operating in a global delivery model, brings strategic direction to testing and acts as the subject matter expert for both the quality discipline and a line of business domain(s). Leads the review of testing artifacts throughout the product life cycle to ensure appropriate sign off and prioritization of testing work. Including coordinating test strategy, scripting and defect resolution. Including ensuring early engagement with internal partners and proactive planning to ensure quality is a core area of focus early in the product lifecycle. Take accountability for quality standards in the development, implementation and upkeep test scripts and opportunities for automation of testing products. Developing meaningful management metrics that help to gauge project health. Identify trends and opportunities for continuous improvement in product release.

PNC Employees take pride in our reputation and to continue building upon that we expect our employees to be:

• Customer Focused - Knowledgeable of the values and practices that align customer needs and satisfaction as primary considerations in all business decisions and able to leverage that information in creating customized customer solutions.
• Managing Risk - Assessing and effectively managing all of the risks associated with their business objectives and activities to ensure they adhere to and support PNC's Enterprise Risk Management Framework.

Successful candidates must demonstrate appropriate knowledge, skills, and abilities for a role. Listed below are skills, competencies, work experience, education, and required certifications/licensures needed to be successful in this position.

Analytical Thinking, Controls Testing, Corporate Governance, Quality Assurance (QA), Quality Support, Software Testing, Test Case Development, Usability Testing

Accuracy and Attention to Detail, Analytical Thinking, Influencing, Process Management, Products and Services, Software Development Life Cycle, Software Quality Assurance And Testing, Technical Documentation Management

Roles at this level typically require a university / college degree, with 3+ years of relevant / direct industry experience. Certifications are often desired. In lieu of a degree, a comparable combination of education, job specific certification(s), and experience (including military service) may be considered.

Bachelors

No Required Certification(s)

No Required License(s)

PNC offers a comprehensive range of benefits to help meet your needs now and in the future. Depending on your eligibility, options for full-time employees include: medical/prescription drug coverage (with a Health Savings Account feature), dental and vision options; employee and spouse/child life insurance; short and long-term disability protection; 401(k) with PNC match, pension and stock purchase plans; dependent care reimbursement account; back-up child/elder care; adoption, surrogacy, and doula reimbursement; educational assistance, including select programs fully paid; a robust wellness program with financial incentives. In addition, PNC generally provides the following paid time off, depending on your eligibility: maternity and/or parental leave; up to 11 paid holidays each year; 8 occasional absence days each year, unless otherwise required by law; between 15 to 25 vacation days each year, depending on career level; and years of service.

To learn more about these and other programs, including benefits for full time and part-time employees, visit Your PNC Total Rewards.

If an accommodation is required to participate in the application process, please contact us via email at Please include "accommodation request" in the subject line title and be sure to include your name, the job ID, and your preferred method of contact in the body of the email. Emails not related to accommodation requests will not receive responses. Applicants may also call and say "Workday" for accommodation assistance. All information provided will be kept confidential and will be used only to the extent required to provide needed reasonable accommodations.

At PNC we foster an inclusive and accessible workplace. We provide reasonable accommodations to employment applicants and qualified individuals with a disability who need an accommodation to perform the essential functions of their positions.

PNC provides equal employment opportunity to qualified persons regardless of race, color, sex, religion, national origin, age, sexual orientation, gender identity, disability, veteran status, or other categories protected by law.

This position is subject to the requirements of Section 19 of the Federal Deposit Insurance Act (FDIA) and, for any registered role, the Secure and Fair Enforcement for Mortgage Licensing Act of 2008 (SAFE Act) and/or the Financial Industry Regulatory Authority (FINRA), which prohibit the hiring of individuals with certain criminal history.

Refer to the California Consumer Privacy Act Privacy Notice to gain understanding of how PNC may use or disclose your personal information in our hiring practices.

We are looking for several Quality Engineers to join our growing Pittsburgh (Cheswick) location! Your Responsibilities: Curtiss-Wright EMD is searching for Quality Engineers to support its Quality Team in the design and manufacture of EMD’s highly engineered products. Since 1952 Curtiss Wright EMD has been integral to the US Navy’s nuclear propulsion program. You will play an important role by helping to implement the quality assurance program to support design, and manufacture ensuring product standards. We Take Care of Our People: Paid Time Off I 401K with Employer Match and Profit Sharing I Health and Wellness Benefits I Learning and Development Opportunities I Referral Program I Competitive Pay I Recognition I Employee Stock Purchase Plan I Inclusive & Supportive Culture Your Challenge: Develop quality assurance data packages Drive continuous improvement within the quality management system Perform internal, process and external audits, surveillances Lead in translation of customer or regulatory requirements into manufacturing instructions Provide technical support to inspectors and operators Present analysis of production data and trends Lead root cause analysis efforts and drive implementation of corrective actions Identify and resolve potential project or supplier quality issues Review, evaluate, and respond to customer and/or supplier correspondence Strong communication skills within a team setting to ensure quality standards are met What you Bring: BS Engineering or related technical degree Must be sole US citizen and be able to obtain and maintain DOD security clearance Strong critical thinking and problem-solving ability 4 plus years of experience in a manufacturing setting Auditing experience is an asset Six Sigma Yellow Belt / Green Belt / Black Belt certifications is desired Ability to read and understanding Geometric Dimensioning and Tolerances (ASME Y14.5) is a plus Who we are: Our Values Environmental, Social and Governance EMD a business unit of Curtiss-Wright in Cheswick, PA designs, manufactures, tests, and provides after-market support for the most advanced, proven and reliable critical function pumps, motors, generators, seals, control rod drive mechanisms and power conditioning electronics available anywhere in the world today. Curtiss-Wright EMD has a long-standing and distinguished reputation for the design, development, manufacture, and qualification of critical-function machining solutions for the United States Navy and the commercial nuclear utility industry. #LI-MO1 No unsolicited agency submittals please. Agency partners must be invited to participate in a search by our Talent Acquisition Team and have signed terms in place prior to any submittal. Resumes submitted directly to any Curtiss-Wright employee or affiliate will not qualify for fee payment, and therefore become the property of Curtiss-Wright. Compliance Statement This position may require exposure to export-controlled information and subject to additional security screening. In the event information provided during the security screening reveals ineligibility to access export-controlled information, any offer of employment may be reconsidered or withdrawn. Curtiss-Wright values diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If you require accommodation due to a disability at any time during the recruitment and/or assessment process, please contact Talent Acquisition and we will make all reasonable efforts to accommodate your request.

Salary Range: $165,000 to $200,000 Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, abilities and working shift. Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision. The Director, Quality Assurance is responsible for ensuring that processes needed for Production Unit QMS requirements are documented, effectively established, and effectively maintained. This position will report to top management on the effectiveness of the quality system and any need for improvement, and this position will ensure the promotion and awareness of applicable regulatory requirements and quality system requirements throughout the organization. This position services as the management representative for the site.

• Responsible for administration of Manufacturing Quality Assurance and Compliance to assure timely delivery of results to manage the company objectives and production as well as new product introduction on time. Reviews procedures of quality systems, validation, change control, manufacturing discrepancy investigations, cGMP/regulatory compliance, and product specifications. Oversees responsibility for the coordination/approval of Periodic Quality Reports (PQRs). Leads regulatory quality inspections of the facility. Assumes responsibility for major projects assigned by Manager.
• Works independently of direct supervision but interacts with all levels within the site organization on a daily basis. Interacts regularly with Regulatory Affairs, Sales, Quality Assurance and Operations, Global Quality Management, and personnel. Routinely interacts with Regulatory Agencies including, but not limited to, FDA and DEA.
• Quality decision authority to Stop production and testing activities and contain materials and productions with immediate effect where critical deviations from regulatory requirements and/or Fresenius Kabi Quality Management System are noted.
• Directly manages the Quality department and performance of local quality systems including document control, training, CAPA, Supplier Controls Internal and External Audits, MQA/Batch Release, and Quality Control.
• Immediate notification to management on confirmed, reportable quality defects that become known from deviations, complaints, and other events and when notification to concerned Competent Authorities is required.
• Immediate notification to management on data integrity issues that become known.
• Regularly assess the quality management system, via internal audits and other applicable monitoring methods.
• Report to top management regarding the compliance and effectiveness of the quality management system.
• Directs investigations of product complaints for manufactured products and completion of appropriate documentation. Provides technical details as required in a manner consistent with the confidential and proprietary nature of the information. Interacts with the Medical Affairs and Vigilance Departments as needed.
• Participates in Regulatory/FDA inspections by providing information or expediting/obtaining information required by the inspectors. Schedules and conducts pre-inspection review of operations and follow-ups where corrective action is required. Facilitate external agency audits, inspections, and visits relative to the quality management system, including audit findings, responses, and corrective and preventative actions, as delegated.
• Ensure the promotion of awareness of customer requirements and regulatory requirements throughout the organization.
• Collection and reporting of Quality KPIs.
• Assurance that all products are released at the site, compliant with the quality management system, registration and GMP requirements.
• Support investigation of incoming complaints.
• Fosters an open environment of continuous improvement that drives quality employee engagement and meets pragmatic business needs.
• Coaches and provides critical quality thinking, mentoring, and appropriate escalation.
• Influences effective compliance-based decisions with cross functional communication and team building skills.
• Interacts with other Quality Units within the division and larger company.
• Ensures adequate training is provided and complete for employees in their respective function.
• Responsible for ensuring the Quality Management System requirements are met under ISO 9001 standards

Requirements

• Bachelor's degree in Engineering or a related field,
• 10 years of previous Quality experience with 5 years in a leadership position
• Computer technical hardware/Software knowledge is a plus
• Knowledge of appropriate FDA, ISO, and global regulations regarding quality systems.
• The ability to effectively communicate with a broad spectrum of people having varying backgrounds, education, and experience.
• Experience dealing directly with FDA and notified bodies required.
• Strong, practical, and pragmatic knowledge of both US and global Quality system requirements and medical device/ biologics production.
• Must have the ability to act as a change agent and drive/influence change as well as effectively lead and motivate team members to achieve goals.

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution, and wellness program.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.

Lead Quality at a Unique SiteRelocation AvailableAbout Our ClientA global specialty materials manufacturer focused on protective solutions for high-reliability applications across industries like automotive, aerospace, energy, and construction. The company emphasizes innovation, quality, and operational excellence while fostering employee ownership and continuous growth.Job DescriptionLead implementation and management of IATF 16949-compliant quality systemsOversee and improve Quality Control procedures to ensure standardization and complianceManage customer portals, audit schedules, and conduct internal, supplier, and product audits (including VDA audits)Lead PPAP submissions and support APQP activities for new product launches and modificationsDevelop and maintain FMEAs and Control Plans throughout the product lifecycleUtilize data analysis and SPC tools to identify root causes and drive corrective actionsCollaborate cross-functionally with Sales, Engineering, R&D, Supply Chain, and Operations to resolve quality issues and support continuous improvement initiatives MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants. The Successful ApplicantMinimum 5 years' experience in an IATF 16949-certified or similar quality environmentStrong expertise in SPC, DOE, and core quality toolsProficient in statistical analysis software such as MinitabSix Sigma training and IATF 16949 auditing certifications preferredExcellent analytical and problem-solving skills with data-driven decision makingEffective communicator with the ability to lead cross-functional teamsBachelor's degree in Chemical Engineering, Chemistry, or a related technical fieldWhat's on OfferCompetitive salary up to $115,000, with potential for higher pay for exceptional candidatesOpportunity to lead quality initiatives at a unique manufacturing siteEmployee ownership stake through a progressive ownership modelExposure to automotive industry standards and certifications like IATF 16949Collaborative and dynamic work environment fostering continuous improvementProfessional growth and development opportunities, including training and certificationsInvolvement in cross-functional projects with global impactContactCian TroyQuote job refJN-062025-6757687