Quality Assurance Engineer

Reference Number: 112717 MAIPBM
Location: MA

Position:  Quality Assurance Manager
Location:  MA

 

 

Description:

 Medical Corporation is focused on developing next-generation medical products based on its state-of-the-art technology. The Quality Manager is responsible for maintenance and continuing improvement of the quality management system (QMS) and compliance with all applicable regulations and standards for medical devices.

 

Duties:

• Responsible  for reviewing, improving and maintaining most aspects of the quality system including the Quality Manual and procedures/processes, including document and data control, quality planning, training, vendor approval / monitoring, equipment calibration, complaint handling and trending, product recalls / advisory notices, corrective and preventive action system, internal quality audits, non-conforming materials, incoming and final inspection

• Reporting on the performance of the quality management and proposing recommendations.

• Support, as needed, regulatory assurance, engineering and Senior Management with regulatory filings, creation of technical files, vigilance / incident reports, internal and external audits, and sign-off for relevant documents

• Conduct product design control activities for new and sustaining product development efforts

• Support risk analysis activities, including design and process FMEA

• Support Process/Design Validation/Verification activities, including software validation and IQ/OQ/PQ activities

• Support Manufacturing Engineering in the creation of DMR, DHR, routers, bills of material, and specifications for in- house / external manufacturing

• Conduct Internal Audits of the Quality System

• Prepare for and participate in audits by external organizations, such as FDA, ISO etc.

 

 

Requirements

 

Experience Desired:

• Experience in Medical Device Quality Assurance, with a minimum 5 years of hands-on management experience is required

• Solid understanding of  applicable regulations, including  FDA  21 CFR Part 820, ISO 13485, Health Canada MDD’s, European MDR’s

• Experience with Medical Device start-ups is a plus

 

Education Required:

• Bachelor’s degree in scientific, biomedical, or engineering discipline required

 • Hands-on and results-oriented, with ability to multitask

• Ability to maintain professional demeanor at all times

 

 Brian Murray
bmurray@photonicsgrp.com
919-572-2292
The Photonics Group