Quality Engineer

Quality Engineer (Med Device)

Comp:
$90K–$110K

Schedule:
Flexible “summer hours” (4x9hr days + half-day Friday)

Overview:

Looking for a hands-on Quality Engineer to support manufacturing and ensure compliance with ISO 13485 and FDA regulations. This role is highly cross-functional and focused on process validation, QMS, and production quality.

Key Responsibilities:

• Lead/support process validation (IQ/OQ/PQ, TMV, qualifications)


• Manage non-conformances, CAPA, and complaint handling


• Support manufacturing line quality and in-line inspections


• Maintain and improve QMS (GMP, GDP, audits)


• Assist with process transfers (prototype → production)


• Collaborate with engineering, operations, and suppliers


• Validation activities

Must-Have Experience:

• 2–5 years in medical device quality/manufacturing


• Strong process validation experience (IQ/OQ/PQ)


• QMS knowledge (ISO 13485, FDA)


• Experience with CAPA, non-conformance, audits


• Comfortable in fast-paced, multi-project environments

Nice to Have:

• Catheter experience


• Contract Manufacturing background


• Class II/III device experience

Perks:

Bonus eligible, PTO, sick time, paid holidays, 401k match