114 Equipment Qualification jobs in Hoffman Estates

JOB SUMMARY

Responsible for inspecting the product to identify quality issues and assisting with product repacking as needed.

RESPONSIBILITIES

• Provide technical, customer relations, and personnel management for major programs and projects.

• Conduct daily walk-through of assigned coolers to check the quality of the product and identify any quality issues.

• Check dates of product for proper product rotation by date.

• Remove any distressed product, determine what product needs reworking and what product should be discarded.

• Rework all distressed/damaged products

• Communicate quality issues to buyers, management, and associates. Report all lost product or transfers.

• Assure that all inventory is properly blocked and labeled.

• Inspects product on production lines; identifies issues and notifies line leads

• Identifies products according to size, origin, and count

QUALIFICATIONS

Education

Prefer High School or GED

Experience

A minimum of two (2) years related experience (knowledge of produce industry preferred).

Skills

• Ability to operate warehouse power equipment.

• Ability to interact with others in a professional manner.

• Good verbal and written communication skills.

• General understanding of the shipping procedures of a high volume warehouse operation.

• Solid understanding of produce varieties handled in a wholesale operation.

Decision Making Authority

Most important decisions made fully independently:

Identifying quality issues, removing the distressed and damaged product

Most important decisions made with review and approval of other individuals or supervisors (include the reviews/approvals required):

All work regularly reviewed by the supervisor and manager.

Physical Demands and Work Environment

Please provide any other information that you think would help us further define the nature and scope of this position.

• Eliminated Produce QC Inspector title.

• Some stooping and bending required.

• Ability to manually inspect produce efficiently for periods of up to or exceeding eight (8) hours.

• They must be able to move around the work area freely.

• Frequent lifting of the product up to 50 lbs. during the shift, infrequent lifting up to 80 lbs.

#LI-DF1

AFFIRMATIVE ACTION STATEMENT:

Applicants must be currently authorized to work in the United States. We are proud to be an Equal Opportunity and Affirmative Action employer, and consider qualified applicants without regard to race, color, creed, religion, ancestry, national origin, sex, sexual orientation, gender identity, age, disability, veteran status or any other protected factor under federal, state or local law. This opportunity is available through Sysco Corporation, its subsidiaries and affiliates.

Title: Quality Assurance Associate

Location: Vernon Hills, IL

Contract Term: 5+ Months

Shift/Hours: 1st Shift ( 8-9am to 4-5pm) / 40hrs

Client: Medical Device Company

Job Category: Quality

Employment Type: Contract on W2 (Need US Citizens Or GC Holders Only)

No H1B’s

Job Description:

Responsible for the efficient and effective review of calibration records and certificates in conformance with regulations and standards.

Responsibilities include review of calibration data, determining final disposition of some laboratory equipment calibration records and detecting nonconforming conditions.

Works within clearly defined SOPs and/or scientific methods. Adheres to quality guidelines.

Complies with regulations and standards. Identifies basic non-compliance within regulations and standards.

Maintains appropriate training / certifications, as needed.

Associates degree in Quality, life sciences, or engineering related field and/or equivalent work experience.

(May be equivalent to 2 years’ experience).

Understanding of the use of calibrated equipment and ability to review and understand equipment maintenance repair procedures and equipment calibration certificates and records.

• Define approach to validating capabilities.
• Develop testing strategies and test plans, including functional testing, regression testing, negative testing, deployment testing , ETL job execution (Control-M/Control Center)testing, and error handling testing.
• Work with business to understand the requirements.
• Work with operations team to coordinate the build deployment and execution within the test environment.
• Track Defects and report on testing progress and results.
• Demonstrate advanced SQL, UNIX, Control-M, Control Center and ETL (Ab Initio) skills.
• Ability to understand the code base by looking at Ab-Initio Psets, graphs(.mp) & XFRs.
• Has required skills to mock-up and upload test data using Ab Initio's Test Data Management tool (TDM).

• Impactful Work: When you join Diasorin, you become part of a team that's dedicated to improving lives. Your contributions will directly impact patient care, making a meaningful difference in the world.

• Global Reach & Innovation: Our work transcends borders. Joining Diasorin means collaborating with colleagues from all over the world, expanding your horizons, and contributing to global healthcare solutions at the forefront of the diagnostic industry.

• Quality System Oversight:
  • Manage and continuously improve the QMS to align with lean manufacturing principles, ensuring it supports product quality, operational efficiency, and regulatory compliance. Lead cross-functional quality initiatives that drive measurable improvements in compliance, productivity, and risk mitigation.
• Regulatory Compliance:
  • Serve as the primary point of contact for regulatory inspections and audits. Maintain up-to-date knowledge of applicable regulations and ensure organizational practices remain compliant. Lead efforts to identify and address compliance gaps proactively.
• Manufacturing Quality & Process Excellence:
  • Provide expert-level technical analysis of product development and manufacturing processes to ensure conformance to specifications and quality standards. Leverage root cause analysis, statistical methods, and lean tools (e.g., FMEA, 5 Whys, value stream mapping) to drive process improvements and reduce non-conformances.
• Training & Leadership:
  • Mentor and develop junior Quality Engineers, fostering a culture of quality, accountability, and continuous improvement. Champion training initiatives to enhance technical competencies and regulatory knowledge across the Quality team.
• Project Participation:
  • Actively participate in cross-functional project teams, representing Quality functions for the Chicago site. Ensure compliance with Design Control requirements throughout the product lifecycle, from concept through commercialization.
• CAPA & Risk Management:
  • Lead and support the execution of Corrective and Preventive Actions (CAPA), ensuring root cause investigations are thorough and utilize appropriate quality tools. Promote a data-driven approach to risk identification, analysis, and mitigation in both development and manufacturing environments.
• Validation & Documentation:
  • Oversee validation planning and execution for manufacturing processes, equipment, and software. Ensure all validation activities are appropriately documented in compliance with internal procedures and external regulatory requirements.
  • Act as Management Representative and IVDR Person Responsible for Regulatory Compliance (PRRC) for the site. In this capacity, ensure that product meets label claims and customer satisfaction, any quality or regulatory issue is elevated to the DiaSorin Molecular President and/or DiaSorin S.p.A Head of Corporate Quality/Regulatory, and oversee and drive continuous improvement of the Quality Systems.
• Among additional duties, the main responsibilities are as detailed in Article 15 of the EU IVDR 2017/746:
• Perform other duties as assigned.

• Bachelor's Degree or relevant field required. Examples could be Engineering or life sciences discipline such as Mechanical, Electrical, Industrial, Manufacturing Engineering, Bioengineering, and/or Quality Engineering.
• Master's degree or relevant field preferred. Examples could be Engineering or life sciences discipline such as Mechanical, Electrical, Industrial, Manufacturing Engineering, Bioengineering, and/or Quality Engineering.
• Minimum 7+ Years management experience in medical device industry, IVD experience
• 5+ Years experience to include at least five years of experience in quality management.
• Specific Licenses and Certifications Preferred: ASQ Certified Quality Engineer, Lean Six Sigma Black Belt, Certified Quality or Biomedical Auditor a plus, but not required.

• Thorough knowledge of International, Federal, State, FDA regulations and ISO 13485 Quality Management Systems is required.
• Must have a thorough understanding and experience in software lifecycle and validation requirements.
• FDA Product and Process Validation Techniques.
• Must be proficient in Microsoft Word, Microsoft Excel and Microsoft PowerPoint.
• Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
• Ability to write reports, business correspondence, and procedure manuals.
• Ability to effectively present information and respond to questions from groups of top management, public groups, managers, clients, and customers.
• Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory and factor analysis.

• Lead, coach, and develop the QA managers and their teams and three Chicago Plants to ensure strong execution of quality and food safety responsibilities across all shifts.
• Ensure compliance with applicable FDA, USDA, and state food safety regulations and customer requirements.
• Oversee facility audits including third-party certifications (e.g., BRC, SQF, AIB), customer inspections, and internal GMP reviews, and all Chicago plants
• Manage and continuously improve programs related to HACCP, HARPC, allergen control, sanitation, pest control, traceability, and product hold/release.
• Collaborate with Operations, R&D, Maintenance, and Sanitation to proactively resolve quality issues and drive root cause corrective actions.
• Lead or support investigations related to product complaints, deviations, and non-conformances.
• Ensure documentation and data integrity across all QA systems, including product testing, calibration records, and process control charts.
• Develop and monitor quality KPIs and present metrics to plant and corporate leadership.
• Partner with HR to ensure QA training programs are maintained and effectively implemented.
• Support implementation of corporate and customer-driven quality initiatives at the site level.

• Bachelor's degree in Food Science or related field.
• Minimum 7-10 years of progressive QA/Food Safety experience in a food manufacturing environment, with at least 5 years in a leadership role.
• Strong knowledge of FSMA, HACCP, GMPs, and food safety regulatory compliance.
• Experience with bakery or high-volume food manufacturing environments strongly preferred.
• Demonstrated success leading teams and managing third-party audits.
• Strong analytical and problem-solving skills; data-driven decision-making required.
• Excellent communication and cross-functional leadership skills.
• Proficiency with QA software systems, Microsoft Office Suite, and ERP platforms (e.g., SAP, Plex, etc.).

• Based full-time on-site at the Corporate HQ in Chicago, with regular travel to three Chicago Plants.
• Must be available to support QA coverage across all shifts as needed.
• Exposure to a manufacturing environment with variable temperatures and allergens.

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What you'll do:

Be a part of our Quality Control Team. We are seeking bright, articulate, detail-oriented, and disciplined people to help delight our customers and grow with us. Work alongside our Fulfillment, Engineering, and Manufacturing teams to deliver a world-class product.

Your role will consist of:

• Inspecting product quality with care
• Receiving and unpacking shipments from our warehouses
• Maintaining our product inventory
• Communicating with our Australian team to coordinate shipments
• Working closely with our Fulfillment team
• Administrative tasks

• Must be at least 18 years of age
• Must have a valid driver's license
• Must be authorized to work in the United States
• Excellent written and verbal communication skills in English
• Basic math skills (addition, subtraction, multiplication, and division)
• Ability to lift up to 49lbs
• Full use of hands and fingers to perform tasks

• Strong attention to detail
• Highly organized
• You're excited to get things done, in a fast-paced environment
• Open to learning new skills
• Ability to work independently as well as in a team environment
• Exhibit good job performance and behavior as measured through indicators such as teamwork, attendance, quality and productivity
• Customer focused
• An ability to problem solve and prioritize tasks to ensure efficiency

• Experience with Excel (or an interest in developing this skill)
• 1+ year of experience working with computers

• Culture Questionnaire
• In-Person Interview

• Attractive hourly pay + equity
• Whatever equipment you need to excel
• 100% company paid insurance (medical, dental, vision, life, and disability insurance)
• 5 weeks PTO per year (vacation, sick, holidays)
• Coaching and training
• Huge opportunities to learn new skills and grow with the company!

• Do the impossible
• Take chances
• Learn continuously
• Are team-oriented
• Strive to know the future

• A highly motivated and experienced Quality Control Lead is sought to ensure the highest standards of food safety and quality within a dynamic processing environment. This role is critical in maintaining regulatory compliance and upholding rigorous quality assurance protocols. The ideal candidate will possess a strong understanding of food safety regulations, quality control procedures, and industry best practices.

• Implement and monitor food safety programs, ensuring regulatory compliance (USDA, FSIS, SQF, etc.).
• Develop and maintain food safety and quality procedures (SSOPs, GMPs).
• Manage CAPA, foreign material control, and facility inspections.
• Oversee quality control checks, sanitation, and microbiological testing.
• Contribute to training programs and mentor QC staff.
• Serve as backup to the Quality Control Supervisor.

• High school diploma/equivalent; experience in food processing (meat preferred) required.
• HACCP certification preferred.
• Strong knowledge of food safety regulations and quality assurance principles.
• Excellent analytical, problem-solving, and communication skills.
• Ability to work in colder temperatures.

• Hybrid 3x a week - Pittsburgh, Strongsville, Birmingham, Dallas, Phoenix

• Archer
• JIR
• Microsoft Office

1. What experiences do you have with testing of technology related controls?
2. What is the hardest challenge that you have encountered and how were you able to resolve?
3. Can you describe the steps taken when executing an assessment on the effectiveness of a control. Please designate the systems and individuals you interacted with.

• Sorting and processing returned materials and submit documentation to necessary departments

• Inspect, verify and document inbound materials before they are released to production.

• Inspect, verify and document incoming damaged freight.

• Create detailed RMA documentation

• Enter information into spreadsheets and maintain records of products and product samples shipped.

• Ensure that our products meet quality and legal standards plus meet the customers' requirements.

• Implementing performance and quality improvement programs.

• Help QA Supervisor with training production staff, on quality measures, etc.

• Prepare letters and other documents as needed.

• Answer and respond to telephone calls and e-mails.

• Must possess a keen eye for details.

• Outstanding written and verbal communication skills are required.

• Able to multi-task when needed.

• Be able to read and interpret manufacturing drawings and blueprints.

• Solid knowledge in metalworking manufacturing such as MIG welding, cutting, bending.

• Able to work independently or with others.

• Any additional duties assigned by supervisor.