**Job Description**
The primary function of this role is to provide technical leadership within Quality Engineering to help support Production, Quality Control, Purchasing, Facilities, IT, Regulatory, Analytical Lab, Research and Development and Engineering Sustaining teams.
This includes but is not limited to providing support to process validation, change requests, non-conforming product issues, corrective and preventive action programs, Design and Process FMEA, risk assessment and associated Quality System Documentation.
Responsibilities:
* Drive all assigned Quality Engineering projects and ensure they are managed in a structured fashion and completed in compliance with the relevant procedures.
* Manage and drive project activities to ensure timely completion of project milestones.
* Represent team at key review meetings.
* Work closely to build effective relationships with other functions in particular Operations, IT, Engineering and Regulatory teams.
* Lead in the area of FDA, QSR and ISO13485 requirements, promoting awareness of best industry practice and making appropriate decisions on a daily basis.
* Identify and implement opportunities for improvement and implements under their own initiative.
* Maintain a proactive approach to developing the quality system to meet the changing needs of the business.
* Ensure that in-house or external quality issues are effectively prioritised and acted upon in a timely manner.
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