Working at Freudenberg: We will wow your world!

Responsibilities:

• Communicate department goals and objectives to others, ensuring workload is distributed appropriately to achieve goals and objectives.

• Lead Carpinteria Quality Review Board (QRB) and Corrective / Preventative Action (CAPA)

• Ensure appropriate actions are taken to resolve quality non-conformances in a timely manner.

• Lead quality engineering improvement projects to completion within defined timelines.

• Reviews and approves Processes Changes, Quality Plans, Validation Protocols/Reports, TMV’s, as necessary.

• Support external audits from customer, notify bodies and regulatory agencies.

• Support the internal audit program by performing audits (internal, external and supplier) and closure of audit concerns.

• Provide support and expertise in the implementation and enforcement of ISO13485,

• QSR, and MDSAP requirements, and any other applicable regulations.

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

• Ensure team personnel are trained appropriately to support required activities.

• Provide leadership and direction on project/product teams as it relates to the quality engineering functions.

• Participate and provide quality reporting for management reviews and scorecards, as needed.

Qualifications:

• Bachelors degree in Engineering or Science-related field.

• 5+ years of increasing experience providing technical support and leadership in regulated environment.

• Knowledge and experience with one or more: ISO 13485, QSR and MDSAP.

• Ability to successfully work in timeline-driven environment.

• Quality Certifications (ASQ CQE, CQA, CQM, etc.) preferred.

• Class I, II, III Medical Device Manufacturing experience in controlled environments and sterilization processes (EO, Irradiation, etc.) preferred.

• Experience in coaching and utilizing performance management tools and disciplines.

• Experience auditing (internal and external) for all elements of ISO 13485 preferred.

• Experience with the successful completion of multiple projects for new product development or improvement initiatives.

• Proficient with statistical analysis, quality tool, GD&T, Gage R&R, and CAPA investigation and resolution.

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