Quality Manager - Relocation Provided

We are seeking an experienced Quality Manager to lead our quality assurance and quality control operations. In this role, you will oversee our Quality Management System (QMS), drive regulatory compliance, and lead a dedicated team of 2–3 Quality Engineers.

The ideal candidate brings strong expertise in ISO 13485 and ISO 9001 standards, a hands-on leadership style, and a proven track record of maintaining high product quality standards in a regulated medical device manufacturing environment.

Key Responsibilities

Team Leadership & Operations

• Manage, mentor, and develop a team of 2–3 Quality Assurance / Quality Control professionals.
• Oversee day-to-day QA/QC operations, including incoming inspection, in-process testing, and final product release.
• Establish key performance indicators (KPIs) for product quality, manufacturing consistency, and supplier management.

Quality System & Compliance

• Maintain, audit, and continually improve the company’s Quality Management System (QMS) to ensure full compliance with ISO 13485, ISO 9001, and FDA 21 CFR Part 820 regulations.
• Serve as the primary point of contact for external regulatory audits, ISO registrar audits, and customer quality reviews.
• Manage the internal audit program, including audit scheduling, execution, report generation, and corrective action follow-ups.

CAPA, Risk Management & Continuous Improvement

• Lead the CAPA (Corrective and Preventive Action) process, ensuring thorough root-cause investigations and effective implementation of corrective measures.
• Oversee Risk Management activities in accordance with ISO 14971, including Risk Management Plans, FMEAs, and Risk Reports.
• Partner cross-functionally with Manufacturing, Engineering, and R&D to support Design History Files (DHF), Process Validation (IQ/OQ/PQ), and Change Control procedures.

Qualifications & Requirements

• Experience: 5+ years of quality engineering/management experience in medical device manufacturing, with at least 2 years in a direct supervisory or management capacity.
• Standards Expertise: In-depth, working knowledge of ISO 13485 and ISO 9001 (FDA QSR 21 CFR 820 familiarity preferred).
• Education: Bachelor’s degree in Engineering, Life Sciences, Quality Assurance, or a related technical field (or equivalent combination of education and experience).

Skills:

• Demonstrated track record of leading root-cause analysis (5-Why, Fishbone) and managing CAPA systems.
• Experience with internal auditing and hosting external ISO/FDA audits.
• Strong communication, cross-functional collaboration, and decision-making skills.

Preferred Qualifications

• ISO 13485 Lead Auditor Certification.
• CQM/OE or CQE certifications from ASQ (American Society for Quality).
• Experience with Lean Manufacturing or Six Sigma methodologies (Green/Black Belt).

Compensation & Benefits

• Base Salary: $120,000 – $150,000 commensurate with experience
• Relocation Support: Comprehensive relocation assistance package available for out-of-area candidates
• Full health, dental, and vision insurance options
• 401(k) retirement plan with company match
• Paid Time Off (PTO) and paid holidays