Quality Assurance Manager

Insight Global; Snoqualmie (WA); Vor Ort; USD 120.000 - 180.000; Vollzeit

Benefits dieser Stelle

Annual bonus

Relocation assistance

Travel support

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Quality leadership

Process validation

Regulatory compliance

Risk management

IQ/OQ/PQ

ISO 13485

Medical device manufacturing

Ausbildung

Bachelor's degree in engineering/technical discipline

Jobbeschreibung

Schedule

6 am - 4:30 pm | 4x10s (Friday - Sunday off)

• 10% bonus (ineligible for 2027 bonus, but 2028 Feb payout would be eligible)

Relocation Support

open to provide for singles/family

• Travel: 5-10% travel (both nationally and internationally)

Job Description

A client of Insight Global is looking to bring on a Quality Manager to help support the MCX Facility. This role has a strong focus within medical device manufacturing quality systems, process validation, and leadership. The first 6 months of the position will be supporting the MCX facility, and then expanding to broader organizational quality initiatives.

Success Indicators

• Lead and enhance Quality Management Systems
• Drive process validation and qualification activities
• Support significant new product introduction (NPI) growth over the next three years
• Act as a quality leader across production, engineering, operations, and customer-facing activities
• Serve as the primary contact for customer audits, regulatory matters, and compliance initiatives

Qualifications

• Bachelor's degree in an Engineering, Biomedical, Biological, Chemical, Pharmaceutical, or related technical discipline.
• Medical device manufacturing experience
• Experience with ISO 13485
• Understanding of IQ/OQ/PQ
• Risk management and change management experience
• Strong background in process validation and qualification

Plusses

• Experience with ISO 9001 and quality system expansion is a plus because we will eventually work towards ISO9001