UK Cambridge QA / QC Scientist

Job Title:               QA / QC Scientist - Medical Devices

Key skills:             QA / QC, Medical Devices

Location:               Cambridge

Duration:               Permanent

My client is developing a range of Distributed Clinical Diagnostics Systems and is looking for a QA / QC Scientist to be responsible for undertaking Quality Assurance, Quality Control and Product release activities to support the companies R&D and operational programs. The job is based at the companies UK facility in Cambridge. In addition the QA/QC Scientist has a key role as an integral member of the company's international QA and Regulatory program based in the US.

Key Responsibilities.
1. To undertake QA activities as assigned by the QA manager.
2. To gather analyse and report company quality data.
3. To undertake final product release reviews.
4. To design, review and approve validation programs.
5. To design and validate quality control tests.
6. Working with operations to process map and identify CTQ's for operational processes.
7. Ensuring that all assigned key project tasks and milestones are met. Where this does not occur to develop and implement action plans to correct and prevent future occurrence.
8. To monitor company CAPPA processes.
9. To maintain the company document control procedures.
10. To be responsible for logging and approving incoming materials.
11. Ensure that all work is carried out in line with company health and safety procedures and policies.
12. Maintaining all written documentation according to company standards.
13. To ensure that all work is carried out to the defined regulatory standards (cGMP's and ISO 13485 2003).

Qualifications
A minimum of degree qualification or equivalent in Biochemistry, or another appropriate chemical/biological science. A recognised quality qualification is highly desirable.

Experience
Typically a minimum of 4 years experience in either Quality Assurance or Quality Control in a medical device manufacturing operation.

Key Skills and attributes
1. Highly developed analytical skills.
2. Highly developed attention for detail.
3. Strong communication skills.
4. Detailed understanding of the requirements of cGMP and ISO 9001 as applied to the manufacturing and R&D environment.
5. Objective and data driven.
6. Strong statistical skills including the development of sample plans.

General
The person should be willing to re-locate to the Cambridge area.
The candidate must be flexible as some international travel will be required (primarily to the US).

Please email a word version of your cv quoting Ref. No. 7b01c and call any time +44 (0)20 8224 9006

Ref: 7b01c