Quality Systems and Compliance Manager

Teledyne FLIR LLC • $96K — $128K *
City Of Industry, CA 91714In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor's degree in Engineering, Quality, Regulatory Affairs, Life Sciences, or related discipline.
  • 5-10 years of quality management experience in a regulated manufacturing environment.
  • Strong knowledge of ISO 9001:2015 and ISO 13485:2016.
  • Expertise in regulatory compliance for EU MDR 2017/745 and FDA requirements.
  • Experience in internal auditing, CAPA, and risk management.

Responsibilities

  • Develop and maintain the Quality Management System (QMS) in compliance with ISO standards and regulations.
  • Ensure effectiveness of QMS processes and report on performance to executive management.
  • Oversee compliance with medical device regulations and support external audits.
  • Manage risk assessment processes throughout the organization.
  • Lead supplier quality management and conduct audits.

Benefits

  • Opportunities for professional development and certification.
  • Mentorship and leadership development.
  • Supportive work environment fostering continuous improvement.
  • Engagement with cross-functional teams and executive leadership.
Full Job Description
Job Description

Summary

The Quality Systems and Compliance Manager is responsible for developing, implementing, maintaining, and continually improving the Quality Management System (QMS) in accordance with ISO 9001:2015, ISO 13485:2016, applicable regulatory requirements, and EU Medical Device Regulation (MDR) 2017/745. This position provides leadership and oversight for quality assurance, regulatory compliance, risk management, supplier quality management, internal audits, corrective and preventive actions, complaint handling, post-market surveillance activities, and management review processes.
The Quality Assurance Manager ensures products and processes consistently meet customer, statutory, regulatory, and organizational requirements while promoting a culture of quality, continuous improvement, and risk-based decision making. Assignments are complex and strategic in nature, requiring independent judgment, technical expertise, and leadership across cross-functional teams.

Essential Duties and Responsibilities include the following, but not limited to:

Quality Management System Leadership
  • Establish, implement, maintain, and continuously improve the organization's QMS in compliance with ISO 9001, ISO 13485, EU MDR, applicable national regulations, and company requirements.
  • Serve as management representative or designated quality leader to ensure QMS processes are effectively established, implemented, maintained, and reported to executive management.
  • Monitor QMS performance through quality objectives, KPIs, trend analysis, and management review reporting.
  • Ensure appropriate process interactions, documented information, and quality records are maintained and controlled.

Regulatory Compliance and MDR
  • Ensure compliance with applicable medical device regulations including EU MDR 2017/745, FDA Quality System Regulation (as applicable), and other global regulatory requirements.
  • Support regulatory inspections, notified body audits, customer audits, certification audits, and governmental inspections.
  • Ensure quality system procedures support technical documentation, device lifecycle controls, vigilance reporting, and post-market surveillance requirements.
  • Support regulatory submissions and product registrations through quality system compliance activities.

Risk Management
  • Promote application of risk-based thinking throughout the organization.
  • Ensure quality activities incorporate risk management principles in accordance with ISO 14971 where applicable.
  • Review and monitor quality risks related to products, processes, suppliers, complaints, nonconformities, and field performance.
  • Ensure risk controls remain effective and are periodically evaluated.

Product and Process Quality
  • Establish and maintain quality plans, inspection strategies, acceptance criteria, validation activities, and process controls.
  • Ensure appropriate verification, validation, qualification, and monitoring activities are performed and documented.
  • Review manufacturing, inspection, testing, and service processes to ensure compliance with established requirements.
  • Support design and development activities by participating in design reviews, verification, validation, and design transfer activities.

Supplier Quality Management
  • Establish and maintain supplier qualification, monitoring, re-evaluation, and approval programs.
  • Conduct supplier audits and assessments using risk-based methodologies.
  • Ensure supplier quality agreements, change notification requirements, and performance monitoring systems are implemented and maintained.
  • Monitor supplier performance metrics and oversee supplier corrective action activities.

Nonconformance, CAPA, and Continuous Improvement
  • Oversee nonconformance management, root cause investigations, corrective actions, preventive actions, and effectiveness verification activities.
  • Ensure timely resolution of quality issues using appropriate problem-solving methodologies.
  • Identify opportunities for continual improvement using data analysis, trend analysis, risk assessment, Lean principles, and process improvement tools.
  • Monitor effectiveness of quality improvement initiatives and report results to leadership.

Audits and Management Review
  • Develop and maintain internal audit programs compliant with ISO 9001, ISO 13485, and MDR requirements.
  • Coordinate internal, supplier, customer, and certification audits.
  • Ensure audit findings are investigated, corrected, and effectively closed.
  • Prepare and present management review data including audit results, customer feedback, process performance, supplier performance, CAPA status, complaints, risk management activities, and regulatory compliance status.

Customer Feedback and Post-Market Activities
  • Ensure customer complaints, feedback, returns, and field issues are evaluated and investigated in accordance with applicable requirements.
  • Support complaint handling, vigilance reporting, adverse event reporting, and field corrective actions as required.
  • Monitor product performance data and post-market surveillance activities to identify trends and improvement opportunities.
  • Ensure customer satisfaction data is analyzed and communicated to management.

Training and Quality Culture
  • Ensure personnel are trained and competent to perform assigned activities.
  • Promote awareness of quality policy, quality objectives, customer requirements, regulatory obligations, and MDR requirements throughout the organization.
  • Mentor and develop quality personnel while promoting a culture of quality and continuous improvement.

Leadership Responsibilities
  • Provide leadership and direction to quality personnel and cross-functional teams.
  • Develop departmental goals, budgets, resource plans, and improvement strategies.
  • Support strategic business objectives while ensuring compliance with quality and regulatory requirements.
  • Interface with executive leadership regarding quality performance, regulatory risks, compliance status, and improvement initiatives.

Additional Competencies
The successful candidate should demonstrate:
  • Strong knowledge of ISO 9001:2015 requirements.
  • Strong knowledge of ISO 13485:2016 requirements.
  • Knowledge of EU MDR 2017/745 requirements.
  • Knowledge of ISO 14971 risk management principles.
  • Internal auditing experience to ISO 9001 and ISO 13485.
  • CAPA, root cause analysis, and risk management expertise.
  • Supplier quality management and auditing experience.
  • Strong regulatory compliance and inspection readiness skills.
  • Data analysis, statistical methods, and quality metric development experience.
  • Effective leadership, communication, and organizational skills.

Education and Experience
Bachelor's degree in Engineering, Quality, Regulatory Affairs, Life Sciences, Manufacturing, or related discipline and minimum 5-10 years of progressively responsible experience in quality management within a regulated manufacturing environment.
Preferred qualifications include:
  • Medical device industry experience.
  • ISO 13485 lead auditor or internal auditor certification.
  • ASQ Certified Quality Manager (CMQ/OE), Certified Quality Engineer (CQE), or equivalent certification.
  • Experience supporting Notified Body, FDA, customer, and certification audits.
  • Experience with MDR technical documentation, post-market surveillance, and supplier quality programs.

Supervisory Responsibilities
This position has direct responsibility for the leadership, development, and performance management of Quality personnel and indirect responsibility for promoting quality compliance throughout the organization. The Quality Assurance Manager provides strategic direction and day-to-day oversight of Quality Assurance, Quality Control, Supplier Quality, Document Control, Internal Audit, Complaint Handling, and Quality Systems activities, as applicable

Other Essential Duties
  • Follows all import/export requirements, consulting with facility import/export personnel as required.

Other Skills and Abilities
  • Working knowledge of Lean Manufacturing/6 Sigma/Kaizen
  • Knowledge of specific software (MS Office, Dynamics AX/CRM, Power Bi)

Other Qualifications
  • Candidate must possess U.S. citizenship or be a "U.S. Person". (A U.S. Person is defined as a person who is a lawful permanent resident "Green Card holder" as defined by 8 U.S.C. 1101 (a)(20) or who is a "Protected Individual" as defined by 8 U.S.C. 1324b(a)(3).


Salary Range:
$96,600.00-$128,800.000

The anticipated salary range listed for this role is only an estimate. Actual compensation for successful candidates is carefully determined based on several factors including, but not limited to, location, education/training, work experience, key skills, and type of position.

About Teledyne FLIR LLC

Teledyne FLIR LLC Careers

Joining Teledyne FLIR LLC presents an unparalleled opportunity to become part of a leading team of professionals dedicated to pioneering technological innovations. As a prominent player in the field of sensory technology, Teledyne FLIR LLC offers a range of job opportunities that cater to a variety of professional skills and experiences.

Explore Career Opportunities

Teledyne FLIR LLC is actively hiring and continually seeks talented individuals who are eager to drive innovation and lead in their fields. The company offers positions that challenge and foster professional growth, ensuring that every team member can contribute to their full potential.

Innovation and Leadership

At Teledyne FLIR LLC, innovation is at the core of everything they do. The company prides itself on a culture of leadership and diversity, promoting an environment where unique ideas and perspectives lead to groundbreaking solutions and advancements in technology.

Professional Growth and Development

Career advancement is a cornerstone of Teledyne FLIR LLC's commitment to its employees. With robust training programs and diversity initiatives, the company ensures that all team members receive the support and resources they need to succeed. Professional growth is encouraged through leadership training, skill development workshops, and networking opportunities within the industry.

Internship Programs and Employment Benefits

For those starting their careers, Teledyne FLIR LLC offers internship programs that provide invaluable industry experience and insights into the company’s operations. Interns work alongside seasoned professionals and are considered integral members of the team from day one. Full-time positions at Teledyne FLIR LLC come with competitive benefits packages that support both personal and professional development. Benefits include comprehensive health coverage, retirement plans, and paid time off, among others.

Join the Teledyne FLIR LLC Team

Teledyne FLIR LLC is looking for passionate, curious, and innovative individuals to join their team. Explore open positions that match your skills and interests on the Teledyne FLIR LLC careers page. Each position offers a unique opportunity to contribute to the company’s mission of enhancing life through innovative sensory solutions.

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Learn more about Teledyne FLIR LLC
Industry
Aerospace & Defense
* Ladders Estimates

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