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Software Quality Leader
This job has expired, and cannot be applied for.
- Posted By: Polytec Personnel
- Address:
- Contact:
- Date Posted: 8th Oct 2008
- Salary: £neg
- Location: Other
- Reference Code: 21232
- Views Since Posting: 64
- Full Description:
Our client is seeking a Software Quality Leader to join the team. This position specifically provides Software Quality Assurance Leadership and Direction within a Medical Device Company. The successful candidate will be accountable for all areas of Software Quality within the company, including the qualification, maintenance and change management of embedded software as well as supporting all other Computer System Validation activities.
ROLE SPECIFIC REQUIREMENTS:
The job holder must be able to demonstrate expert knowledge, leadership and experience in Software Validation within a Medical Device organisation (or similarly regulated industry) with a track record in the validation of complex manufacturing processes and product qualification to support 510K submissions and product CE marking.
You will have the ability to demonstrate a strong knowledge of ISO13485 / ISO9001, BS EN 62304, 21 CFR Part 820 and 21 CFR Part 11 is required, be able to demonstrate effective People Management, Leadership and facilitation skills. You must be an excellent communicator both written and verbally. You should also have experience of influencing others whilst promoting the importance of building quality into all aspects of work by operating as an ambassador to the Quality Management System.
You must be able to manage complex issues across multiple sites and be in a position to coordinate and influence multiply activities at once. The job holder should be receptive to working in a fast-paced, constantly changing work environment that demands a step up from their comfort zone on a day to day basis. You must be able to get up to speed quickly and be able to juggle the never-ending demands of a high workload AND be solution focused, motivated by delivery of results and a job well done.
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