Quality System / Design Control SpecialistLocation BirminghamCompetitive SalaryMy client is looking for someone who can cover New Product Development (NPD), Quality Assurance (QA) and change...
Quality Systems Specialist - Audits
Are you experienced working with quality systems under ISO13485 and FDA regulations? Are you looking for the next move in your career where you will be able to influence the direction of a multinational biotechnology company that has shown continued growth over the past 5 years? My client is looking for a suitable qualified individual who has experience working on the quality system of medical device to join their QA team and are offering an attractive package.
Job Purpose:To conduct internal and supplier audits as Lead Auditor to meet regulatory requirements and follow up to ensure any deficiencies are appropriately addressed i.e. NCRs and CAPAsKnowledge and Skills
Essential:Biological or chemical based degree or equivalent.Qualified Lead Auditor.Training in FDA Quality System Requirements.Full understanding of ISO13485 / FDA QSR.CAPA Management.Audit planning, execution and follow-up.Able to manage multiple projects.Good problem-solving skills and attention to detail.Excellent communication skills - both verbal and written.
Desirable:Process and equipment validation training attendedJapanese Ordinance 69/ISO9001, Health Canada and CMDCAS requirements.Experience of research and development of biological and chemical based products.IVD DirectiveKnowledge of antibody/ antigen reactions.
To discuss this role and the company informally please call Ellie on 0121 7288458.