Quality Manager - Relocation Provided

Genuine Search Group; Seattle (WA); On-site; USD 120,000 - 150,000; Full time

Benefits offered by this job

Relocation assistance

Health insurance

Dental & vision insurance

401(k) matching

Job summary

Genuine Search Group is seeking an experienced Quality Manager in Seattle to lead QA/QC and own the Quality Management System (QMS). You will drive regulatory compliance for ISO 13485 and ISO 9001, plus FDA QSR, while managing a small team of Quality Engineers.

The role requires hands-on leadership and a proven record of maintaining high product quality in a regulated medical device environment. Competitive salary with relocation support and comprehensive benefits are provided.

Qualifications

• 5+ years of quality engineering/management experience in medical device manufacturing.
• 2+ years in direct supervisory or management capacity.

Responsibilities

• Lead QA/QC operations and team of 2-3 Quality Engineers.
• Oversee day-to-day QA/QC processes including incoming inspection, in-process testing and final release.
• Maintain and improve QMS to ensure ISO 13485, ISO 9001 and FDA 21 CFR Part 820 compliance.
• Drive CAPA processes with thorough root-cause investigations and corrective actions.
• Collaborate with Manufacturing, Engineering and R&D on DHF, IQ/OQ/PQ and Change Control.

Skills

CAPA leadership

Root cause analysis

Auditing & regulatory

Cross-functional collaboration

Decision making

Education

Bachelor’s degree in Engineering/Life Sciences/QA

Job description

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

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