Senior Manager Quality Systems

Working at Freudenberg: "We will wow your world!" This is our promise. As a global technology group, we not only make the world cleaner, healthier and more comfortable, but also offer our 52,000 employees a networked and diverse environment where everyone can thrive individually. Be surprised and experience your own wow moments.

Freudenberg Medical is a trusted Contract Manufacturing Organization (CDMO) partner, delivering high-quality solutions from ideation and market launch to volume production for medical device and pharmaceutical companies. With proven expertise in materials and technologies, Freudenberg Medical offers an extensive range of vertically integrated capabilities: precision molding and extrusions, complex catheters, hypotubes, and coatings.

• 401K Match:
  Save for retirement with the company's help.
• Diversity & Inclusion:
  We focus on providing an inclusive environment and recognize our diversity contributions to our success.
• Performance Related Bonus:
  When you have an impact, you can reap the rewards.
• Corporate Events:
  We celebrate success as a team, because only together can we achieve our goals.
• Sustainability & Social Commitment:
  We support social and sustainable projects and encourage employee involvement.
• Candidates must be legally authorized to work in the United States without current or future visa sponsorship.

We offer a comprehensive benefits package that includes medical, dental, and vision coverage, retirement savings with company match and paid time-off. Additional details will be shared during the recruitment process.

Beverly, MA

On-Site

Freudenberg Medical LLC

Payments. The expected salary range for this position is $130,000 to $175,000 annually, depending on skills, experience, and qualifications.

• Lead the development, deployment, and continuous improvement of a harmonized global QMS aligned with internal policies, ISO 13485, FDA (21 CFR 820/QMSR), EU MDR, and other applicable regulations.
• Establish standard work, governance, and KPIs to ensure consistent audit execution and audit readiness across all sites.
• Act as global process owner for key quality system elements, including internal audits, external audits, CAPA effectiveness, and risk management.
• Develop and execute a global, internal audit program across all manufacturing sites and functions.
• Ensure readiness for regulatory, customer, and notified body audits; provide leadership during inspections (front room/back room support).
• Identify systemic gaps and drive timely, effective remediation and CAPA closure.
• Develop and implement compliance risk assessment model identifying and prioritizing high risk areas.
• Partner with site Quality, Operations, and Engineering teams to improve product quality and Quality System effectiveness through a robust CAPA process.
• Lead and coach complex investigations into product failures, complaints, and quality signals using structured root cause methodologies.
• Drive global alignment on root cause analysis (RCA) standards, tools, and training.
• Ensure effective integration of risk management activities (e.g., FMEA, hazard analysis) into product and process improvements.
• Partner with Quality leaders across regions and sites to ensure consistent interpretation and application of Corporate QMS requirements.
• Support site leadership in regulatory interactions and compliance strategies.
• Influence cross-functional stakeholders to enable risk-based decision making and a proactive quality culture.
• Build and sustain a culture of compliance, accountability, and continuous improvement.
• Lead training initiatives to strengthen audit readiness, RCA capability, and quality system effectiveness.
• Mentor and develop Quality leaders and key talent across the organization.

• University degree in Engineering, Life Sciences, or related field.
• 10+ years of progressive experience in Quality and/or Regulatory Affairs within the medical device industry.
• Proven experience in medical device, component manufacturing in multi-site or global manufacturing environments.
• Demonstrated leadership in developing and maintaining ISO 13485, MDSAP, FDA (21 CFR 820/QMSR), EU MDR, ISO 14971, and FDA-compliant Quality Management systems.
• Solid understanding of process validation, design and development, and risk management activities as they relate to medical devices and components for medical devices.
• Effective communicator with strong strategic, analytical, and leadership skills.
• Ability to balance strategic leadership with operational execution.
• Demonstrated experience leading global audit programs and regulatory inspections.
• Proven track record in root cause analysis, CAPA, and product quality improvement.
• Experience managing and developing teams in a global, matrixed organization.
• Business leadership role requires domestic and international travel (up to 40%).

The Freudenberg Group is an equal opportunity employer that is committed to diversity and inclusion. Employment opportunities are available to all…