Job Description
Summary :
Participate in the New Product Development (NPI) and design changes, Design History File (DHF) and Device Master Record (DMR) reviews meetings and fully understand the design control process and Quality Engineering. Utilize technical training and compliance experience to ensure that company design control projects comply with internal design control procedures in accordance with FDA and ISO requirements.
Roles & Responsibilities:
- A seasoned, experienced professional with a full understanding of design control process; resolves a wide range of issues in creative ways.
- Responsible for assuring projects meet customer expectations, and regulatory requirements.
- Act as a subject matter expert on design control process and Quality Engineering. The Quality Engineering subjects are Risk Management, Test Method Validation (TMV), Statistics, Reliability Engineerin...