Medical Device Quality Engineer II — Design Controls (Contract)

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

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.