5,793 Quality Management System jobs in the United States

Job Summary

The Senior Manager, QMS has responsibility for Inogen’s Quality Management System (QMS) including compliance with applicable regulations and standards, system performance, strategic leadership, and oversight of quality initiatives. This role is based in Plano, TX and ensures that all products and processes comply with regulatory standards, company policies, and industry best practices. The Senior Manager will lead the QMS team to achieve quality objectives and continuous improvement.

Responsibilities

• Develop, refine, and maintain the Quality Management System to ensure compliance with ISO 13485, FDA regulations, EU MDR, and other relevant standards and to achieve long-term quality strategies and business initiatives.
• Manage and maintain a team of QMS professionals per the approved budget and annual operating plan. Provide development and guidance to staff on quality management practices and standards.
• Support development of annual department budget and resource planning.
• Lead internal and external audits, including regulatory inspections, and ensure timely and effective resolution of audit findings.
• Collaborate with cross-functional teams to define and support creation or improvements to SOPs and work instructions.
• Monitor and report on QMS metrics within monthly reviews and periodic Management Reviews, identifying areas for improvement and implementing corrective actions.
• Manage the CAPA process, ensuring effective root cause analysis and implementation of corrective and preventive actions.
• Ensure that all product documentation, including Design History Files and Device Master Records, are accurate and complete.
• Support product development teams in risk management activities and ensure that risk management procedures are established and assessments are conducted and documented.
• Stay current with industry trends and advancements, ensuring the QMS evolves to meet changing requirements.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or a related field; advanced degree preferred.
• Minimum of 8 years of experience in quality management within the medical device industry, including at least 5 years of managing a Quality Assurance team.
• Experience at companies with over $1B revenue.
• Strong knowledge of ISO 13485, FDA regulations, and other relevant quality standards.
• Proven track record of leading successful audits and regulatory inspections.
• Excellent leadership and team management skills.
• Strong analytical, problem-solving, and decision-making abilities.
• Effective communication and interpersonal skills.
• Detail-oriented with a strong commitment to quality and compliance.

Job Summary

The Senior Manager, QMS has responsibility for Inogens Quality Management System (QMS) including compliance with applicable regulations and standards, system performance, strategic leadership, and oversight of quality initiatives. This role is based in Plano, TX and ensures that all products and processes comply with regulatory standards, company policies, and industry best practices. The Senior Manager will lead the QMS team to achieve quality objectives and continuous improvement.

Responsibilities

• Develop, refine, and maintain the Quality Management System to ensure compliance with ISO 13485, FDA regulations, EU MDR, and other relevant standards and to achieve long-term quality strategies and business initiatives.
• Manage and maintain a team of QMS professionals per the approved budget and annual operating plan. Provide development and guidance to staff on quality management practices and standards.
• Support development of annual department budget and resource planning.
• Lead internal and external audits, including regulatory inspections, and ensure timely and effective resolution of audit findings.
• Collaborate with cross-functional teams to define and support creation or improvements to SOPs and work instructions.
• Monitor and report on QMS metrics within monthly reviews and periodic Management Reviews, identifying areas for improvement and implementing corrective actions.
• Manage the CAPA process, ensuring effective root cause analysis and implementation of corrective and preventive actions.
• Ensure that all product documentation, including Design History Files and Device Master Records, are accurate and complete.
• Support product development teams in risk management activities and ensure that risk management procedures are established and assessments are conducted and documented.
• Stay current with industry trends and advancements, ensuring the QMS evolves to meet changing requirements.

Qualifications

• Bachelors degree in Engineering, Life Sciences, or a related field; advanced degree preferred.
• Minimum of 8 years of experience in quality management within the medical device industry, including at least 5 years of managing a Quality Assurance team.
• Experience at companies with over $1B revenue.
• Strong knowledge of ISO 13485, FDA regulations, and other relevant quality standards.
• Proven track record of leading successful audits and regulatory inspections.
• Excellent leadership and team management skills.
• Strong analytical, problem-solving, and decision-making abilities.
• Effective communication and interpersonal skills.
• Detail-oriented with a strong commitment to quality and compliance.

Actual Position Title: Onboarding Specialist, CAR T

Location: Cell Therapy Operations Summit, New Jersey

Purpose And Scope Of Position: This role is responsible for working on New Hire Orientation Program (NHOP) for the Summit West Cell Therapy Operations organization, as well as the accurate and timely processing of all training requests related to NHOP. The primary function.

• Develop and implement quality assurance policies and procedures to ensure compliance with ISO standards and regulatory requirements.
• Manage and lead the quality assurance and quality control team to ensure effective testing and quality checks.
• Conduct regular audits of processes and products to identify areas for improvement and ensure adherence to quality standards.
• Oversee the development and execution of testing protocols, including manual and automation testing.
• Utilize root cause analysis to investigate quality issues and implement corrective actions to prevent recurrence.
• Collaborate with cross-functional teams to promote quality awareness and ensure quality practices are integrated into all aspects of production and development.
• Analyze quality data and metrics to identify trends, risks, and opportunities for process improvement.
• Facilitate training sessions for staff on quality standards, documentation, and best practices in quality control.
  
  

• Bachelor's degree in Quality Assurance, Engineering, or a related field.
• Minimum of 5 years of experience in quality assurance and quality control roles, with at least 2 years in a management position.
• Strong knowledge of ISO standards and regulatory compliance requirements.
• Proven experience in testing methodologies, including software testing, automation testing, and manual testing.
• Excellent analytical and problem-solving skills with a focus on continuous improvement.
• Strong documentation skills with the ability to create and maintain quality manuals and policies.
• Experience in risk management and root cause analysis.
• Ability to work collaboratively in a team environment and communicate effectively with all levels of the organization.
  
  

• Full Benefits
• 3 Weeks PTO
• Company vehicle
  
  

• Please do NOT change the email subject line in any way. You must keep the JobID: linkedin : RC L784 -- in the email subject line for your application to be considered.***
  
  

• Develop and implement quality assurance policies and procedures to ensure compliance with ISO standards and regulatory requirements.
• Manage and lead the quality assurance and quality control team to ensure effective testing and quality checks.
• Conduct regular audits of processes and products to identify areas for improvement and ensure adherence to quality standards.
• Oversee the development and execution of testing protocols, including manual and automation testing.
• Utilize root cause analysis to investigate quality issues and implement corrective actions to prevent recurrence.
• Collaborate with cross-functional teams to promote quality awareness and ensure quality practices are integrated into all aspects of production and development.
• Analyze quality data and metrics to identify trends, risks, and opportunities for process improvement.
• Facilitate training sessions for staff on quality standards, documentation, and best practices in quality control.
  
  

• Bachelor's degree in Quality Assurance, Engineering, or a related field.
• Minimum of 5 years of experience in quality assurance and quality control roles, with at least 2 years in a management position.
• Strong knowledge of ISO standards and regulatory compliance requirements.
• Proven experience in testing methodologies, including software testing, automation testing, and manual testing.
• Excellent analytical and problem-solving skills with a focus on continuous improvement.
• Strong documentation skills with the ability to create and maintain quality manuals and policies.
• Experience in risk management and root cause analysis.
• Ability to work collaboratively in a team environment and communicate effectively with all levels of the organization.
  
  

• Full Benefits
• 3 Weeks PTO
• Company vehicle
  
  

• Please do NOT change the email subject line in any way. You must keep the JobID: linkedin : RC -- in the email subject line for your application to be considered.***
  
  

QA/QC Director – Fairfield, NJ

Summary:

The QA/QC Director is primarily responsible for the development and implementation of quality management systems. Establishing quality standards and procedures as well as monitor compliance and regulatory requirements.

Responsibilities

• To ensure that the production facility is operating at a high operational and compliance standard.
• Lead, coach and manage a team of chemists to ensure data integrity and performance to meet business objectives
• Monitor each department’s operations to ensure that all procedures are being adhered to and that only approved products or services are being delivered to the company’s clients.
• Oversee the entire department, ensuring that proper procedures are being followed when approving each product or service.
• Ensure that deadlines are met
• Train and develop colleagues
• Assist employees to solve problems, using quality management techniques
• Consult with the quality managers and other personnel to design quality strategies and goals for the department, which will be implemented by employees
• Help to promote the implementation of quality systems throughout the company
• Develop and implement policies relating to all operations in accordance with company objectives. Ensure these policies are adhered to by personnel under your supervision and that appropriate records are kept for future reference
• Keep management informed on product quality and any concerns that may influence this measure, such as complaints from customers or suppliers, etcetera
• Other duties assigned by Management

Education:

• Bachelor’s degree in a scientific discipline with a minimum of 10 years’ experience in quality management

Experience Requirements:

• Experienced with liquid manufacturing and packaging of Rx products.
• Experience with Empower 3
• Experience working in an FDA regulated environment
• Experience with ANDA and NDA submissions
• Experience with validations of processes, cleaning, analytical methods, facilities and equipment
• Knowledge of CFR & ICH Regulatory Guidelines
• Knowledge of cGMP processes and GDP.

Computer Skills:

• Microsoft Word
• Microsoft Excel
• Empower 3

Other Requirements:

• Has significant technical knowledge of quality management principles.
• In depth knowledge of all laboratory equipment, practices, and procedures
• Ability to think logically and independently
• Demonstrated managerial abilities
• Problem analysis, solving and resolution skills
• Has excellent oral and written skills
• Has excellent interpersonal skills
• Is self motivated
• Has a very high attention to detail
• Has a positive attitude
• Must speak, read, and write in English

You must be able to work in the U.S. without sponsorship. No C2C or 3rd parties, please.

We're hiring an experienced QA/QC Manager to support a greenfield data center construction project in New Albany, OH. This is a high-impact role for someone who understands the complexity of electrical installations and thrives in a detail-driven, fast-paced construction environment.

This is an on-site role focused on maintaining and overseeing all aspects of the project's quality assurance and control plan. You’ll report directly to the Project Manager and coordinate with on-site and off-site teams, subcontractors, and stakeholders to ensure compliance, safety, and precision across the board.

Key Requirements:

• Hands-on experience with high voltage electrical projects
• Strong command of construction quality regulations
• Exceptional attention to detail and documentation
• Ability to communicate effectively with all levels – from tradespeople to leadership
• Previous experience in greenfield or data center construction strongly preferred
• Skilled in electrical inspections, walk-downs, and system testing
• Comfortable with tools like Excel, Word, and QA documentation systems

What You'll Be Doing:

• Implement and manage the project’s QA/QC plan
• Oversee subcontractor compliance and coordinate inspections
• Lead documentation processes – from submittals and logs to final as-builts
• Conduct walk-downs, material tracking, shop drawing reviews, and 4-phase inspections
• Maintain testing records, rework lists, and support third-party audits
• Actively ensure the project stays on track, safe, and within quality specs

Additional Info:

• Must be able to read and interpret blueprints, specs, and system documentation
• Prior work with systems like CSA, CX mapping, Bus Duct, Cable Bus, and MV/LV gear
• Physical ability to move around large construction sites and wear PPE daily
• 15+ years in QA/QC for heavy industrial construction preferred

If you're someone who takes pride in doing it right the first time, keeps quality at the forefront, and is ready for a major project, let’s talk.

Job Description

HiFyve is working with a company in Alma, GA that is hiring for a Quality Assurance Supervisor in the Food and Beverage Industry. 

$60k-$80k + bonus 

Full Benefits Package 

Day Shift

Key Responsibilities

• Maintain and update HACCP protocols in collaboration with the Food Safety Coordinator and management.
• Implement and monitor quality, sanitation, and SSOP programs to ensure food safety and regulatory compliance.
• Serve as the lead contact for third-party audits, preparing and managing all necessary QA and food safety documentation.
• Maintain records related to label approvals and ensure accurate documentation for products produced.
• Work with food safety, technical service, and QA teams to manage product specifications (including allergen, nutritional, and formulation data).
• Distribute new product information and specifications to relevant departments.
• Oversee quality review during initial production runs of new items.
• Manage quality incident reporting and follow up on product issues.
• Develop and maintain customer product specifications and conduct shelf life studies as needed.
• Promote and execute quality and food safety policies, procedures, and training programs across the facility.
• Assist with SSOP documentation and addressing USDA-related matters.

Qualifications

• Bachelor’s degree in Animal Science, Meat Science, or a related field is preferred.
• Minimum of two years’ experience in QA and/or Food Safety within meat processing.
• At least two years of management experience in QA and Food Safety.