Senior Quality Engineer – Medical Devices


Beverly, MA

Empowering people, creating technology.

  • Lead in the development of direct reports to achieve desired results. Collaboratively create development plans and coach individuals in achieving them.

  • Communicate department goals and objectives, ensuring resources are distributed appropriately.

  • Ensure Quality department’s participation in the Growtth (Lean) program.

  • Ensure systems and specific product procedures are in place to release product meeting defined requirements.

  • Responsible for leading the development and management of an effective and compliant quality system by working closely with various cross-functional members.

  • Ensure quality performance metrics are implemented, monitored and addressed.

  • Report to management on the performance of the Quality Management System.

  • Participate in strategic planning activities to ensure that quality related requirements are included in strategic goals and objectives while promoting quality awareness throughout the site.

  • Lead / oversee customer / external audit(s)

  • Develop relationship with customer quality management and address customer concerns to support strategic approach to the regulations as the primary contact.

  • Serve as site Management Representative

  • Conduct management review meetings and ensure closures of management review items.

  • Ensure continuing suitability, adequacy, and effectiveness of Freudenberg Medical Quality Management System

  • Oversee CAPA Review Board (CRB) and ensure appropriate actions are taken to resolve QNs in a timely manner.

  • Responsible for implementing new or revised global quality systems requirements

  • Report and resolve customer recalls and field complaints.

  • Bachelor’s degree

  • 7 years of Quality, Manufacturing, and/or Product Development, experience.

  • 5 years minimum of medical device experience.

  • 5+ years experience in demonstrated ability to manage, coach and mentor employees.

  • Experience in a metric driven culture.

  • Previous experience participating in or leading a Quality audit or section of an audit.

  • ISO Quality Systems requirements and FDA GMP and QSR.

  • Electronic Quality Management System.

  • Able to review and analyze data and documentation.

  • Effective and competent management, leadership, and organizational skills required and valued as part of the leadership team.

  • Good reasoning abilities and sound judgment.

  • Ability to communicate effectively (written & spoken) as required for job related communication throughout the organization.

  • Trustworthy, discrete and a high degree of personal integrity to maintain sensitive and confidential information.

  • Accurate and attentive to detail.

  • Excellent communication and presentation abilities.

  • Ability to lead and support others.

  • Ability to read and interpret documents.

  • Experience leading and managing customer interaction.

  • Ability to manage 8 direct reports.

  • Experience with audits.

  • Experience in a Quality Assurance leadership role

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.

Freudenberg Medical LLC ID:uDnQdo