Sr Quality Engineer

We are looking for a Sr Quality Engineer to support the integration of an OEM capital equipment product. The Sr. Quality Engineer will provide design assurance direction in the areas of risk management, DFMEA, test method validation, specification/sample plan criteria, design verification/validation, process validation and DHF organization/content Review OEM documentation to verify alignment of the marketing/product specifications and ensure overall compliance of product design controls in accordance with company policies, procedures and regulatory requirements. Develop, refine and document program quality plans. Identify critical performance features and work closely with supply chain, operations and supplier quality personnel to ensure adequacy of related process controls. This includes inspection instructions, test method development/validation, periodic control testing and sampling plan selection. Assist in the development of a technical file including essential requirements, design verification, biocompatibility, packaging, labeling and risk management overviews.


The qualified candidate MUST have:

Bachelors degree in Engineering
Minimum of 8 years experience with Medical Devices
Knowledge of ISO 13485 and QSR regulatory requirements relating to Design Control
Design verification and validation testing
IEC 60601 test requirements
Demonstrated statistical skills (CQE, CRE) and/or training in Six Sigma.
REQUIREMENTS
Bachelors degree in Engineering
Minimum of 8 years experience with Medical Devices
Knowledge of ISO 13485 and QSR regulatory requirements relating to Design Control
Design verification and validation testing
IEC 60601 test requirements
Demonstrated statistical skills (CQE, CRE) and/or training in Six Sigma.