Qualifications

• Bachelor's degree in Mechanical, Electrical, Industrial Engineering, or a related technical field is required.
• 5+ years of experience in Quality Engineering or Manufacturing Engineering or 3+ years with a master's degree is needed.
• Certification in Lead Auditor (ISO 13485), ASQ Certified Quality Engineer (CQE), or Six Sigma Green/Black Belt is preferred.
• Direct experience in the Medical Device industry and familiarity with regulations (ISO13485, FDA, EUMDR) is mandatory.
• Experience working with Contract Manufacturers or 3rd Party Suppliers is preferred.

Responsibilities

• Conduct rigorous supplier audits and qualification assessments to ensure compliance with quality standards.
• Lead the Production Part Approval Process (PPAP) to validate components in collaboration with suppliers.
• Own and manage the Material Review Board (MRB) process for non-conforming materials to minimize production downtime.
• Issue and oversee Supplier Corrective Action Requests (SCARs) for significant quality failures.
• Manage root cause analysis using advanced problem-solving techniques to address technical defects swiftly.
• Collaborate with Engineering during new product introduction to ensure supplier capability aligns with design requirements.
• Analyze quality performance metrics to prepare supplier scorecards and conduct quarterly business reviews.

Benefits

• Hybrid work schedule offering flexibility between remote and in-office work.
• Opportunity for professional growth through complex problem-solving in a high-paced environment.
• Travel opportunities for site visits, enhancing practical experience with suppliers.
• Engagement in continuous improvement projects utilizing Six Sigma and Lean methodologies.
• Collaborative work environment with cross-functional teams, enhancing interpersonal skills.