Quality Assurance Specialist – PCR-based IVD
Our client is a growing and highly-respected developer of PCR-based PoC in vitro diagnostic devices. The QA/RA Specialist will support the Director of Quality & Regulatory Affairs by assisting in maintaining an appropriate quality environment for the development and manufacture of products that meet the needs of European and other Regulators as the Company moves towards becoming a leading clinical diagnostics company.
- Participate fully as a member of the Quality Team within and across the business;
- Direct Quality and Regulatory support to all departments within the business.
- Collaborate with internal and external stakeholders to ensure all our processes comply; with the relevant standards and regulations;
- Collate and provide KPI’s, trend data and statistical analysis for Management Review and any other review boards where requested;
- Provide guidance on Risk Management activities;
- Provide guidance, support and maintain the Non-Conformance/Deviation system;
- Provide guidance and perform Root Cause Analysis into CAPA investigations;
- Assist in the review of Technical, Medical Device and Design History Files;
- Create, review, advise and provide guidance on interpretation of SOP’s;
- Review, advise and provide guidance on interpretation of Regulatory requirements;
- Review Verification and Validation Data Reports and SOP’s and provide support during the Validation activities;
- Provide assistance with the maintenance of the electronic and hardcopy record archives;
- Perform Audits to a predefined schedule;
- Participate and support in external Inspections and Audits with clients, distributors and Notified Bodies;
- Provide support and guidance for new product development projects.
- Perform other appropriate duties as assigned
Knowledge Skills and Abilities Required:-
- Attention to detail.
- Organisational and prioritisation skills.
- Strong written and verbal communication skills.
- Problem solving.
- Ability to work alone
- Ability to work part of a team.
- Working knowledge of ISO 13485.
- BSc in a Biological Science based degree.
- Proven experience (3 years or more) of working in Quality Assurance in the IVD or IVDD Medical Device Industry
Based North West
Negotiable salary + Benefits
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