Job Type
Full-time
Description
Position SummaryPart of the Business Unit Leadership Team, the Director of Quality - Metals, is directly accountable for multi-site Quality Management System (QMS) performance, operational quality execution, and multi-jurisdictional regulatory compliance. Reports directly to the VP, Quality & Regulatory. This role drives enterprise scaling toward a $650M MedTech CDMO platform through unified quality governance, lowering the Cost of Poor Quality (CoPQ), and accelerating NPI design transfers.
Job Responsibilities- Strategic Planning & Divisional Operations Alignment: Partner with leadership to resource, execute, and enforce business goals while ensuring strict alignment with ISO 13485, 21 CFR 820, ISO 14971, and global regulatory standards.
- QMS & Regulatory Compliance: Own and uphold site-level QMS compliance to customer quality requirements, registrar standards, and regulatory agency mandates. Serve as Management Representative, drive FDA/Notified Body audit readiness, and participate in centralized Hub-and-Spoke CQP harmonization sprints.
- Corrective & Preventive Action (CAPA) Ownership: Direct the rapid resolution of non-conformances across divisional operations with thorough, root-cause-driven CAPAs. Ensure systemic lessons learned are institutionalized across multi-site operations to prevent recurrence.
- Quality KPIs & Performance Dashboards: Measure Quality KPIs to analyze trends and drive quality performance in partnership with the manufacturing team, as well as divisional operations and quality functional leaders. Design, deploy, and maintain a comprehensive executive Quality Dashboard tracking First Pass Yield (FPY), Cost of Poor Quality (CoPQ), Non-Conformance (NC) timeliness, and CAPA cycle times.
- Manufacturing Quality & Operational Excellence: Lead site Quality Engineering and Inspection teams to maximize First Pass Yield (FPY) and eliminate waste through aggressive Material Review Board (MRB) oversight and zero-defect initiatives.
- Customer Quality Assurance: Lead customer quality relations, direct complaint investigations, conduct rigorous root-cause analyses, issue RMAs, and establish stringent service-level reporting metrics (CPM, GDP, Response Time).
- Supplier Quality Integration: Collaborate with Supplier Quality Engineering to institute incoming inspection protocols, resolve supplier non-conformances, and enforce strict SCAR closure timelines.
- Management Review & Risk Mitigation: Spearhead executive Quality Management Reviews (QMR), escalating systemic risks and driving targeted continuous improvement initiatives across site footprint.
- Talent Leadership & Accountability: Recruit, mentor, and cultivate quality engineering and compliance personnel, establishing clear ownership, performance metrics, and succession pipelines.
- Travel: 20%-25% travel required (including Fairfield, CA, Mebane, NC, and customer sites).
Requirements
- Bachelor's degree in Mechanical, Chemical, Material Science, Plastics, or related engineering/technical field.
- Experience: 12+ years of related experience in medical device manufacturing with proven leadership experience.
- Regulatory Standards: Deep working knowledge of ISO 13485, ISO 14971, ISO 17025, MDSAP, and 21 CFR 820.
- Technical Competencies: Expertise in QMS design/implementation, root cause analysis methodologies (5-Why, Fishbone, 8D), Design Controls / NPI transfers, statistical process control (SPC), Design of Experiments (DOE), Lean Manufacturing, and Six Sigma.
Benefits: Medical/Dental/Vision Insurance, Short-Term Disability, Long-Term Disability, Life Insurance, Paid Vacation Days, Paid Holidays, 401k.
The salary estimates are estimates from this job board and not a guarantee from Biomerics' salary range.
Biomerics does not accept non-solicited resumes or candidate submittals from search/recruiting agencies that are not already on Biomerics' approved agency list. Unsolicited resumes or candidate information submitted to Biomerics by search/recruiting agencies not already on Biomerics approved agency list shall become the property of Biomerics, and if Biomerics subsequently hire the candidate, Biomerics shall not owe any fee to the submitting agency.
