Our client an early-stage company developing an innovative medical device technology are looking to expand the team to support its development and manufacturing activities with the recruitment of a Quality Manager. Reporting to the COO the Quality Manager 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

• 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.