Director of Quality – Metals

🔥 0 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🔴 Lead

👔 Director

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Biomerics

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1994

🏥 Healthcare

💼 Consulting

🏭 Manufacturing

Healthcare • Consulting • Manufacturing

Biomerics is a medical device contract manufacturer specializing in the development and manufacturing of complex interventional components and devices. With expertise in engineering innovative solutions, Biomerics offers a wide range of capabilities from polymer and metal expertise to in-house custom compounding. The company serves as a strategic partner to original equipment manufacturers (OEMs) in the medical industry, providing end-to-end solutions from design to final assembly. Biomerics is known for its minimally invasive device expertise and strategic global locations, offering customer-focused, scalable manufacturing solutions.

📋 Description

• Partner with leadership to resource, execute, and enforce business goals while aligning with ISO 13485, 21 CFR 820, ISO 14971, and global regulatory standards • Own and uphold site-level QMS compliance with customer quality requirements, registrar standards, and regulatory agency mandates • Serve as Management Representative and drive FDA/Notified Body audit readiness • Participate in centralized Hub-and-Spoke CQP harmonization sprints • Direct rapid resolution of non-conformances through root-cause-driven CAPAs • Institutionalize systemic lessons learned across multi-site operations • Measure Quality KPIs and drive quality performance with manufacturing, divisional operations, and quality leaders • Design, deploy, and maintain an executive Quality Dashboard tracking FPY, CoPQ, NC timeliness, and CAPA cycle times • Lead site Quality Engineering and Inspection teams to maximize FPY and eliminate waste through MRB oversight and zero-defect initiatives • Lead customer quality relations, complaint investigations, root-cause analyses, RMAs, and service-level reporting • Collaborate with Supplier Quality Engineering on incoming inspection protocols, supplier non-conformances, and SCAR closure • Lead executive Quality Management Reviews, escalate systemic risks, and drive continuous improvement • Recruit, mentor, and develop quality engineering and compliance personnel

🎯 Requirements

• Bachelor’s degree in Mechanical, Chemical, Material Science, Plastics, or related engineering/technical field • 12+ years of related experience in medical device manufacturing with proven leadership experience • Deep working knowledge of ISO 13485, ISO 14971, ISO 17025, MDSAP, and 21 CFR 820 • Expertise in QMS design/implementation • Expertise in root cause analysis methodologies, including 5-Why, Fishbone, and 8D • Expertise in Design Controls / NPI transfers • Expertise in statistical process control (SPC) • Expertise in Design of Experiments (DOE) • Expertise in Lean Manufacturing and Six Sigma • Willingness to travel 20%–25%

🏖️ Benefits

• Medical/Dental/Vision Insurance • Short-Term Disability • Long-Term Disability • Life Insurance • Paid Vacation Days • Paid Holidays • 401k