QA Manager, Medical Device Quality & NPI Lead

Insight Global; Snoqualmie (WA); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Annual bonus

Relocation assistance

Travel support

Job summary

Insight Global is seeking a Quality Manager to support the MCX Facility with a strong focus on medical device quality systems, process validation, and leadership. The role begins by supporting the MCX site and expands to broader organizational quality initiatives.

The candidate will lead QMS improvements, drive qualification activities, and partner across functions to ensure regulatory readiness and successful audits.

Qualifications

• Bachelor's degree in an engineering, biomedical, biological, chemical, pharmaceutical, or related technical discipline is required.
• Experience in medical device manufacturing and working with ISO 13485 quality systems.
• Understanding IQ/OQ/PQ and risk management processes is required.
• Strong process validation and qualification background is essential.

Responsibilities

• Lead and enhance Quality Management Systems within the MCX facility and beyond.
• Drive process validation and qualification activities across manufacturing.
• Support new product introductions and quality initiatives over the next three years.
• Act as quality leader across production, engineering, operations, and customer-facing activities.
• Serve as primary contact for customer audits, regulatory matters, and compliance initiatives.

Skills

Quality leadership

Process validation

Regulatory compliance

Risk management

IQ/OQ/PQ

ISO 13485

Medical device manufacturing

Education

Bachelor's degree in engineering/technical discipline

Job description

Insight Global is seeking a Quality Manager to support the MCX Facility with a strong focus on medical device quality systems, process validation, and leadership. The role begins by supporting the MCX site and expands to broader organizational quality initiatives.

The candidate will lead QMS improvements, drive qualification activities, and partner across functions to ensure regulatory readiness and successful audits.