Quality Manager Reporting to the COO this position will be responsible for quality system, quality aspects of internal manufacturing, oversight of sub-contract manufacturing partners and support of internal projects. Role/ Responsibilities: • Maintain company's Quality Management System (QMS) and report on the performance of the QMS to the company's Senior Management Team • Supervision of Quality Technicians and Quality Engineers. Lead quality personnel in the completion of required departmental activities including objectives/ goals. • Quality system oversight: management reviews, quality review and internal audit programme • Supplier control including: supplier audits, SCARs, performance monitoring and quality agreements • Manufacturing validation including: MVP development, PFMEAs, validation protocols and reports • Customer complaints: approval of analysis reports and analysis of complaint trends. • CAPA/NCR: oversight of the investigation and timely closure of CAPA and NCRs • Lot release: Routine sterilisation and lot release • External audits: lead the company in regulatory agency quality management system audits including FDA and Notified Body • Operations support: provide effective and responsive QA support to Operations to meet their area’s objectives of quality, cost and output. • Communicate with all functional groups to ensure awareness of quality requirements. • Update of the QMS to meet evolving regulatory and business requirements Qualifications & Experience: • Bachelors in a scientific discipline required with 4 years’ experience in the medical device or pharmaceutical industry; strong analytical skills, exceptional writing and interpersonal relationship skills or a combination of relevant work experience and education. • Demonstrated knowledge of ISO 13485 and 21 CFR 820 requirements • Ability to work as part of a team and meet targets/goals efficiently. • Demonstrated organisational, management and communication skills. • Good interpersonal & communication skills essential • Strong knowledge of quality principles and the ability to utilize these methods in development and manufacturing environments
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