Design Quality Engineer II

Shoolin Inc; Irvine (CA); On-site; USD 71,635; Part time

Job summary

A medical device company is seeking a Design Quality Engineer II to support new product development and ensure regulatory compliance for innovative medical devices. The ideal candidate should possess strong experience in FMEA, DFMEA/PFMEA, and CAD interpretation, with a background in ISO 13485 and FDA standards preferred. This entry-level contract position is perfect for those passionate about quality assurance in medical technology.

Qualifications

• Strong experience in FMEA, DFMEA/PFMEA, and CAD interpretation.
• Medical device experience is a must.
• Strong background in ISO 13485, FDA, and design controls preferred.

Responsibilities

• Support new product development and design controls.
• Manage risk and ensure regulatory compliance for medical devices.

Skills

FMEA

DFMEA/PFMEA

CAD interpretation

Validation and Verification (V&V)

Regulatory compliance

Job description

Design Quality Engineer II – Medical Devices

$52/hr on W2 (All Inclusive)

We’re seeking a Design Quality Engineer II to support new product development, design controls, risk management, V&V, and regulatory compliance for innovative medical devices.

Ideal candidates have strong experience with FMEA, DFMEA/PFMEA, CAD interpretation, V&V, and working cross-functionally in regulated environments.

• Medical Device experience is a must
• Strong background in ISO 13485, FDA, and design controls is preferred

How to Apply: Ready to take the next step? Apply now or send your resume to [e-mail] or DM for more details.

Seniority Level

• Entry level

Employment Type

• Contract

Job Function

• Quality Assurance

Industries

• Staffing and Recruiting

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