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 :
- 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.
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 requirementsAbility to work as part of a team and meet targets / goals efficiently.Demonstrated organisational, management and communication skills.Good interpersonal & communication skills essentialStrong knowledge of quality principles and the ability to utilize these methods in development and manufacturing environments.