Main characteristics
- Location
- Girton, Cambridgeshire
- Company
- Polytec Personnel Ltd
- Salary
- £40000 - £45000/annum
- Employment type
- Permanent
- Category
- Medical / Pharmaceutical / Scientific
Job summary
Location: Cambridge (CB3)Duration: Permanent
Hours: 8am until 4pm (Monday to Friday)
Salary: £40,000 to £45,000
Job Reference: 35202
Polytec are looking for a Quality Engineer for our client based in Cambridge.
Responsibilities:
* Quality representative for assay workflow, product and software development
* Providing QA expertise, identifying opportunities for QMS improvements, and leading the implementation of those improvements
* Developing, planning, conducting internal audit, and following on to closure of the audit non-conformances (Internal/external)
* Supporting and overseeing internal calibration, incoming materials and supplier process
* Lead in solving quality related problems within production and assay teams (ISO 15189)
* Lead for the introduction of new products lines from development to operations, inspection plan, production documentation and risk assessments
* Monitoring quality KPI's
Requirements:
* Experience of working to ISO9001, FDA 21 CFR Part 820 and GMP
* Proven combined experience in Pharma, ISO 9001 operation environment
* IT literate with skills in other Electronic QMS systems
* Good problem-solving abilities
* Excellent communication and influencing skills for both internal and external parties
Please contact us as soon as possible for more details or apply below