QA Specialist, IVD, Medical Devices
Our client is a highly respected developer and manufacturer of IVD assays for the international clinical market. Further expansion and alignment means they now wish to appoint a QA Specialist to their North West based quality team.
This position is responsible for:
- Assisting in the set up and maintenance and management of ISO 13485 compliant Quality Management System in particular Advisory notices, recalls, FSCAs vigilance reporting.
- Collaborating internally to ensure all processes comply with relevant IVD and ISO 13485 regulations;
- Providing support to cross-functional GLP and GCLP / GCP audits, performing internal audits to a predefined schedule
- Leads the activities associated with the development of corrective and preventive actions, and close-out required as a result of internal and external audits.
- Identifying relevant quality related training needs and delivering training, and then to develop and present training sessions
- Providing expertise on the design, implementation and development of ISO 13485 systems, processes and procedures. Provide review, advice and guidance on interpretations, regulatory requirements and SOPS and participate as requested by management during inspections and audits by third parties
- Source of information for quality indices and key performance indicators for management review, preparation reports for and attending Management Review
- The upkeep and further improvement of the Quality Systems and processes to ensure optimum compliance with relevant corporate and regulatory policies.
- Assisting with Supplier Qualification Assessments, supplier audits, identify quality improvement needs and opportunities;
- QA Support for Process / Method / Equipment / Computer Systems Validations
- Thorough understanding of FDA 21 CFR Part 820 and ISO 13485 regulations for In Vitro Diagnostic Devices
- Experienced in risk assessment and risk management processes
- ISO 13485 Internal Auditor is desirable
- Attention to detail and organisational skills are paramount, as well as strong written and verbal communication skills. Strong regulatory background within the pharmaceutical industry is essential. Auditing skills (training and SOPS) and Strong Proof Reading Skills.
- Conversant with FDA & MHRA regulatory requirements
- Experienced and knowledgeable in a wide range of internal auditing techniques, regulatory requirements, process Improvement and problem solving skills
- Extensive experience with auditing, compliance and SOP development.
KNOWLEDGE SKILLS AND ABILITIES REQUIRED
BSc in a Biological Science together with proven experience (3 years or more) of GxP Quality Assurance, ideally spanning ISO 13485, ISO 9001 and In Vitro Diagnostic Devices within a pharmaceutical or biotech company
Location: North West
Salary Negotiable basic + excellent benefits
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