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Details
Quality Manager
Reference: | JCAO2802 | Location: |
Galway |
Qualification: | Degree | Experience: | 7-9 Years |
Job Type: | Permanent | Salary: | Not Disclosed |
May be suitable for:
QA Manager, Quality Manager
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
Skills & 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.
For further information please contact James Cassidy [email protected] or call in confidence 086 0204322
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