Director of Quality

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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, we offer 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 contributes to our success.
• Performance Related Bonus
  :
  When you have an impact, you can reap the rewards.
• Sustainability & Social Commitment
  :
  We support social and sustainable projects and encourage employee involvement.
• Relocation Allowance
  :
  When you move close to our locations we offer financial aid to support you.

• Lead and assist in the development of direct reports to achieve desired results.
• Communicate department goals and objectives, ensuring resources are distributed appropriately.
• Maintain regular two‑way dialogue with direct reports on work and results.
• Collaboratively create development plans and coach individuals in achieving them.
• Ensure the Quality department’s participation in the Growth (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.
• Act as the primary contact for customers regarding quality‑related issues/activities.
• Lead / oversee customer / external audit(s).
• Address customer concerns to support a strategic approach to the regulations.
• Serve as site Management Representative.
• Coordinate and 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.
• Participate in strategic planning activities to ensure that quality‑related requirements are included in strategic goals and objectives.
• Provide quality solutions to support business activities and other assigned tasks to support the business.
• Promote the awareness of quality throughout the business.

• Bachelor’s degree in Science, Engineering, Manufacturing or related field (Master's degree preferred).
• Thorough knowledge of medical devices quality systems (ISO
  13485/FDA).
• Knowledge of LEAN and Six Sigma methodologies is desirable.
• A minimum of ten (10) years of relevant progressive experience within a similar environment, with five or more successful years in a leadership position.
• Thorough knowledge of quality management systems and associated regulatory requirements (ISO 13485, FDA etc.).
• Experience using SAP ERP software and proficiency in Microsoft Office Suite.
• Demonstrable ability to achieve goals through collaborating, influencing and interacting at all levels across the business/function.

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.