Director of Quality - Metals

Company Overview

Biomerics is a world-class manufacturer and innovative polymer solutions provider for the medical device and biotech industries. As a vertically integrated company, we specialize in designing, developing, and producing medical devices for diagnostic and interventional procedures. We are focused on next-generation solutions for vascular access, electrophysiology, cardiac rhythm management, neurovascular, structural heart, and cardiovascular markets.

At Biomerics, we are dedicated to our diverse employee base. We understand that a strong, skilled, and engaged workforce is the foundation of our continued success as a business. We strive to live up to the Biomerics values in all our interactions. It is an exciting time to be part of our collective team, and there is no limit to the impact that can be achieved here at Biomerics.

We improve and advance our employees' lives and the lives of the patients who depend on our products.

At Biomerics, we are guided by our core values of integrity, partnership, empowerment & accountability, trust, agility, teamwork, and excellence. We deeply care about our team members and customers, and our team-oriented, customer-focused corporate culture places a premium on building strategic, mutually beneficial partnerships. Joining our team means becoming part of a dynamic, innovative, and caring community.

Position Summary

Part 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).