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. *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. How we support teamwork You support our team as Senior Manager Quality Systems. Some of your Benefits Performance Related Bonus Corporate Events Sustainability & Social Commitment Location: Beverly, MA On‑Site Trip Origin: Freudenberg Medical LLC Payments: The expected salary range for this position is $130,000 to $175,000 annually, depending on skills, experience, and qualifications Qualifications 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 applicants and associates without regard to race, color, religion, creed, gender (including pregnancy, childbirth, breastfeeding, or related medical conditions), gender identity or expression, national origin, ancestry, age, mental or physical disability, genetic information, marital status, familial status, sexual orientation, protected military or veteran status, or any other characteristic protected by applicable law. #J-18808-Ljbffr