Design Quality Engineer 8/20/2016

MAETRICS Warsaw, IN

Company
MAETRICS
Job Classification
Full Time
Company Ref #
28907804
AJE Ref #
575945925
Location
Warsaw, IN
Job Type
Regular

JOB DESCRIPTION

APPLY
**8 Design QualityEngineers needed for Design Remediation project**

Top Reasons to Work with Us
1. 3 decades of experience as a life sciences compliance consulting firm
2. Super work environment
3. Working on positively impacting patient care and medical device in communities we live and work

WHAT YOU WILL BE DOING
Design Quality Engineer: Work as independent reviewers and advisors to Product Development Engineers that are going to compile the required information to build the remediated Design History Files.
The Design Quality Engineers will provide guidance to PDEs to build the appropriate documentation to support Design Controls (21CFR820.30) Design Inputs/Outputs, Design Review, Design V direct experience compiling and reviewing Device History Files (DHFs)
* Design History File remediation experience
* Understanding of 21CFR 820.30 Design Controls
* Able to work with cross-functional team (product development, marketing, manufacturing engineering, purchasing/logistics, operations) to meet/deliver assigned objectives on time.
* Experience with Orthopedic Surgical Instrument is a PLUS

**MUST HAVES: DO NOT APPLY IF YOU DO NOT MEET THE FOLLOWING

* Design Control experience: ISO 13485, 21 CFR 820.30, and ISO 14971.
* Experience in Medical Devices PD/R&D/Design Quality and DHF Remediation.
* US Citizen
* Available immediately, WITHIN 2 WEEKS