Overview
Quality Manager Jobs in Galway, County Galway, Ireland at Cpl
Title: Quality Manager
Company: Cpl
Location: Galway, County Galway, Ireland
Quality Manager 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. 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 Qualifications & 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
