Quality Manager, Medical Devices | ISO 13485 & QMS Expert

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

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.