Our client a start up based here in Galway are looking to hire a Quality Manager as they expand operations.
The Role:
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.
Responsibilities:
1. Maintain company's Quality Management System (QMS) and report on the performance of the QMS to the company's Senior Management Team
2. Supervision of Quality Technicians and Quality Engineers. Lead quality personnel in the completion of required departmental activities including objectives/ goals.
3. Quality system oversight: management reviews, quality review and internal audit programme
4. Supplier control including: supplier audits, SCARs, performance monitoring and quality agreements
5. Manufacturing validation including: MVP development, PFMEAs, validation protocols and reports
6. Customer complaints: approval of analysis reports and analysis of complaint trends.
7. CAPA/NCR: oversight of the investigation and timely closure of CAPA and NCRs
8. Lot release: Routine sterilisation and lot release
9. External audits: lead the company in regulatory agency quality management system audits including FDA and Notified Body
10. Operations support: provide effective and responsive QA support to Operations to meet their area's objectives of quality, cost and output.
11. Communicate with all functional groups to ensure awareness of quality requirements.
12. Update of the QMS to meet evolving regulatory and business requirements.
Requirements:
13. 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.
14. Demonstrated knowledge of ISO 13485 and 21 CFR 820 requirements
15. Ability to work as part of a team and meet targets/goals efficiently.
16. Demonstrated organisational, management and communication skills.
17. Good interpersonal & communication skills essential
18. Strong knowledge of quality principles and the ability to utilize these methods in development and manufacturing environments.