Our client, an early-stage company developing innovative medical device technology, is 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 will be responsible for the quality system, quality aspects of internal manufacturing, oversight of sub-contract manufacturing partners, and support of internal projects.
Role/ Responsibilities:
* Maintain the company's Quality Management System (QMS) and report on the performance of the QMS to the company's Senior Management Team.
* Supervise 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 the QMS to meet evolving regulatory and business requirements.
Skills & Experience:
* Bachelor's 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.
For further information please contact James Cassidy at james.cassidy@lifescience.ie or call in confidence 086 0204322.
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