Director, Quality and Compliance

Freudenberg Group; Beverly (MA); On-site; USD 165,000 - 200,000; Full time

Benefits offered by this job

Medical, dental, and vision coverage

Retirement savings with company match

Paid time-off

Job summary

A global technology group is seeking a Director, Quality and Compliance in Beverly, MA. This role demands a leader with over 15 years of experience in quality and regulatory affairs within the medical device industry. The candidate should have a university degree in Engineering or Life Sciences, proven expertise in ISO 13485 and FDA-compliant systems, and the ability to communicate effectively. Attractive salary range of $165,000 to $200,000 annually and comprehensive benefits offered.

Qualifications

• 15+ years of progressive experience in Quality and/or Regulatory Affairs within the medical device industry.
• Proven experience in medical device and component manufacturing.
• Demonstrated leadership in developing and maintaining ISO 13485- and FDA-compliant QMS systems.
• Knowledge of FDA QSR, EU MDR/MDD, and other international regulatory frameworks.

Skills

Leadership skills

Communication skills

Analytical skills

Education

University degree in Engineering or Life Sciences

Job description

Overview

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.

Benefits

*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.

Location: Beverly, MA — On-Site

Salary

The expected salary range for this position is $165,000 to $200,000 annually, depending on skills, experience, and qualifications

You support our team as

Director, Quality and Compliance

Responsibilities

Qualifications

• University degree in Engineering, Life Sciences, or related field.
• 15+ years of progressive experience in Quality and/or Regulatory Affairs within the medical device industry.
• Proven experience in medical device and component manufacturing.
• Demonstrated leadership in developing and maintaining ISO 13485- and FDA-compliant QMS systems.
• Knowledge of FDA QSR, EU MDR/MDD, and other international regulatory frameworks.
• Effective communicator with strong strategic, analytical, and leadership skills.

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. #LI-MEDICAL