Director of Quality - Metals

Biomerics; United States; Sur place; USD 180 000 - 240 000; Plein temps

Avantages offerts par ce poste

Medical/Dental/Vision Insurance

Short-Term Disability

Long-Term Disability

Life Insurance

Paid Vacation Days

Paid Holidays

401k

Résumé du poste

Biomerics, a world-class medical device and biotech polymer solutions provider, seeks a Director of Quality - Metals to lead QMS performance across sites and ensure regulatory compliance. This role reports to the VP of Quality & Regulatory and aims to support growth toward a $650M MedTech CDMO platform.

The position oversees CAPA, supplier quality, and customer quality assurance, driving FPY improvements and CoPQ reductions while mentoring the quality team. Travel expected 20–25%.

Qualifications

• Bachelor’s degree in Mechanical, Chemical, Materials Science, Plastics, or related engineering/technical field.
• 12+ years of experience in medical device manufacturing with leadership experience.
• Deep working knowledge of ISO 13485, ISO 14971, ISO 17025, MDSAP, and 21 CFR 820.

Responsabilités

• Partner with leadership to align quality goals with ISO 13485, 21 CFR 820, ISO 14971, and global standards.
• Own site-level QMS compliance and regulatory mandates; serve as Management Representative.
• Lead CAPA with root-cause analyses and drive systemic improvements across sites.
• Develop and monitor KPIs and dashboards for FPY, CoPQ, NC timeliness, and CAPA cycles.
• Lead Quality Engineering and Inspection teams to maximize FPY and reduce waste.
• Manage customer quality relations, investigations, RMAs, and SLA reporting.
• Collaborate with Supplier Quality to enforce incoming inspection and SCAR timelines.
• Lead executive QMRs and drive continuous improvement across site footprint.
• Recruit and mentor quality personnel with clear ownership and performance metrics.
• Travel: 20%–25%.

Connaissances

QMS design/implementation

Root cause analysis

Design Controls/NPI transfers

SPC

DOE

Lean Manufacturing

Six Sigma

Regulatory affairs

Formation

Bachelor’s degree in Mechanical, Chemical, Materials Science, Plastics, or related engineering/technical field

Outils

Minitab

Description du poste

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.

Job Type

Full-time

Description

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.

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.