Quality Engineer: Medical Devices & Compliance

Riverpoint Medical; Portland (OR); On-site; USD 70,000 - 95,000; Full time

Benefits offered by this job

Medical, Dental and Vision insurance

401(k) with company match

Paid Time Off

8 company paid holidays

Job summary

Riverpoint Medical in Portland, Oregon is seeking a Quality Engineer to join their team in delivering premium medical devices. The role involves overseeing quality assurance processes, managing complaint analysis, and ensuring regulatory compliance.

Ideal candidates will hold a BS in Engineering with at least 3 years of experience in the medical device industry. The position offers competitive benefits including health insurance, 401(k) with match, and paid time off.

Qualifications

• 3+ years of related experience in the medical device industry.
• Experience in an ISO13485 or FDA regulated environment is desirable.
• Ability to perform complaint analysis and product failure investigations.

Responsibilities

• Oversee the complaint handling process and perform analysis.
• Collaborate on Medical Device Reporting (MDR) requirements.
• Coordinate multiple quality management systems including CAPA.

Skills

Complaint analysis activities

CAPA planning

Failure Mode Effects Analysis (FMEA)

Technical writing

Computer skills (Word, Excel)

Education

BS in Engineering

MS in Engineering

Job description

Riverpoint Medical in Portland, Oregon is seeking a Quality Engineer to join their team in delivering premium medical devices. The role involves overseeing quality assurance processes, managing complaint analysis, and ensuring regulatory compliance.

Ideal candidates will hold a BS in Engineering with at least 3 years of experience in the medical device industry. The position offers competitive benefits including health insurance, 401(k) with match, and paid time off.