Quality Assurance Team Leader
12 month Fixed Term Contract (potential to go permanent)
To support the Quality Manager in co-ordinating the actions and continuous improvement activities of the team in meeting customer quality requirements which will include the maintenance of Quality Assurance systems throughout the Ramsbury site.
The key responsibilities are:
- Ensuring a safe and clean working environment is maintained.
- Leading site quality activities and site quality team in accordance with policy and procedures.
- Ensuring effective communication within the team.
- To lead the actions and continuous improvement activities of the team in meeting customer quality requirements which; will include the maintenance of Quality Assurance systems throughout the Ramsbury site.
- Internal and external audits to ISO9001/ISO13485 standards
- To lead and drive the Quality System to ensure timely closure of Customer Complaints, Internal Non-conformances and Supplier non-conformance. Assisting as necessary with identifying root cause to prevent recurrence.
- Facilitate reporting and actions on internal and external customer complaints.
- Monitoring and reporting KPI's in line with business requirements
- Assist with the reduction of scrap.
- Ensuring incoming goods are conforming to specification.
- Ensure key raw material specifications are aligned to customer specifications.
- Ensure all bio-burden and pest controls are compliant to standard.
- Represent the site in second and third party audits.
- Supporting the development of new product & generation of technical tiles for new and existing product.
- Perform other activities as required.
- Problem solving and decision making
- Team player, and able to work on own initiative
- Good eye for detail
- Adopt a "can do" approach and fosters within the team
- Ability to work under pressure and to tight deadlines
- PC literate with a high standard of communication skill, both verbal and written.
- The ability to work using own initiative when required, but also showing aptitude as a team player.
- Medical device knowledge of CE, and GMP
- Risk Management in the area of ISO 14971
- Experience of EU product submissions, license renewals, and periodic updates and registrations to regulatory agencies (EU regulatory entities) for medical devices
- Technical file compilation
Additional desirable skills, experience and qualifications:
- Lead Auditor Qualified
- Lean/6 Sigma Qualified
- Good Laboratory Practices (21 CFR Part 58)
- Bioburden, Biocompatibility, and Microbiological Testing
- Recall Experience
- The manufacture of bonding and adhesive components
Vivid Resourcing are committed to equality of opportunity for all applications from individuals are encouraged regardless of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships or any other characteristic protected by law.