Director of Quality – Metals

This is a fully remote position, open to applicants in United States.

📋 Description

• Collaborate with leadership to allocate resources, implement, and uphold business objectives while ensuring alignment with ISO 13485, 21 CFR 820, ISO 14971, and international regulatory standards.

• Take ownership of site-level QMS compliance, ensuring adherence to customer quality expectations, registrar standards, and mandates from regulatory agencies.

• Act as Management Representative and facilitate audit preparedness for FDA/Notified Bodies.

• Engage in centralized Hub-and-Spoke CQP harmonization initiatives.

• Oversee the swift resolution of non-conformances through root-cause analysis-driven CAPAs.

• Institutionalize lessons learned systematically across operations at multiple sites.

• Evaluate Quality KPIs and enhance quality performance in collaboration with manufacturing, divisional operations, and quality leaders.

• Create, implement, and sustain an executive Quality Dashboard that monitors FPY, CoPQ, NC timeliness, and CAPA cycle times.

• Lead site Quality Engineering and Inspection teams to optimize FPY and minimize waste through MRB oversight and zero-defect initiatives.

• Manage customer quality interactions, complaint investigations, root-cause analyses, RMAs, and service-level reporting.

• Collaborate with Supplier Quality Engineering on incoming inspection protocols, supplier non-conformances, and SCAR resolutions.

• Conduct executive Quality Management Reviews, highlight systemic risks, and promote continuous improvement.

• Recruit, mentor, and nurture quality engineering and compliance staff.

⛳️ Requirements

• Bachelor’s degree in Mechanical, Chemical, Material Science, Plastics, or a related engineering/technical discipline.

• Over 12 years of relevant experience in medical device manufacturing with a track record of leadership.

• Extensive knowledge of ISO 13485, ISO 14971, ISO 17025, MDSAP, and 21 CFR 820.

• Proficiency in QMS design and implementation.

• Expertise in root cause analysis techniques, including 5-Why, Fishbone, and 8D methodologies.

• Strong background in Design Controls and NPI transfers.

• Proficient in statistical process control (SPC).

• Experienced in Design of Experiments (DOE).

• Knowledgeable in Lean Manufacturing and Six Sigma methodologies.

• Willingness to travel 20%–25% of the time.

🏝️ Benefits

• Medical/Dental/Vision Insurance

• Short-Term Disability

• Long-Term Disability

• Life Insurance

• Paid Vacation Days

• Paid Holidays

• 401k