Description
Duties:- Provide documented approval of DHF artifacts. Confirming compliance of DHF to requirements.
- Generate design assurance artifacts required by PDP/design controls.
- Facilitate Risk Management activities.
- Ensuring design control requirements are met.
- Develop equipment, fixtures and methods required to perform inspections, including gage R&R's.
- Investigate potential field issues and/or product failures, conduct risk analysis and analyze business impact to generate data for management to use in field action decision-making.
- Confirm compliance of engineering changes to change control requirements.
- Provide documented approval for DMR post-market changes.
- Confirm and/or establish statistically valid sample sizes for engineering changes and V&V activities.
- Perform Product Investigations to provide data for making field action. decisions.
Education: Bachelor's degree required
Experience: 8+ years in Quality Engineering; 4+ years preferably in the medical device industry.
Please be in contact as soon as possible for this urgent position.
To find out more about Real please visit www.realstaffing.com