Job Details

Join to apply for the Quality Engineering Supervisor role at Freudenberg Medical.

At Freudenberg Medical, we make products that save and improve lives worldwide. We are a global provider of medical device design and manufacturing, with over 2,500 employees. We prioritize innovation, quality, and continuous improvement, offering a dynamic environment for career growth.

Benefits include:

• 401K Match
• Personal Development opportunities
• Diversity & Inclusion initiatives
• Sustainability & Social Commitment
• Team-building events

Location: Carpinteria, CA (On-Site)

Salary: $100,000 - $125,000 per year

Responsibilities:

• Communicate department goals and manage workload distribution.
• Lead the Quality Review Board (QRB) and CAPA processes.
• Address quality non-conformances promptly.
• Lead quality improvement projects.
• Review and approve process changes, quality plans, validation protocols/reports, and TMVs.
• Support external audits and internal audit programs.
• Ensure compliance with ISO 13485, QSR, MDSAP, and other regulations.
• Maintain systems and procedures for product release.
• Train team personnel appropriately.
• Provide leadership in project/product teams related to quality engineering.
• Participate in management reviews and scorecards.

Qualifications:

• Bachelor's degree in Engineering or Science-related field.
• 5+ years of experience in a regulated environment with leadership roles.
• Knowledge of ISO 13485, QSR, MDSAP.
• Experience with medical device manufacturing and sterilization processes preferred.
• Quality certifications like ASQ CQE, CQA, CQM are a plus.
• Experience with auditing, project management, statistical analysis, and quality tools.

We are an equal opportunity employer committed to diversity and inclusion. Employment is open to all qualified applicants.

Seniority level

• Mid-Senior level

Employment type

• Full-time

Job function

• Quality Assurance, Management, and Manufacturing

Industries

• Medical Device Manufacturing