Talent.com
This job offer is not available in your country.
Quality Manager

Quality Manager

Collins McNicholasGalway, Connaught, IE
18 days ago
Job description

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 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.
  • Create a job alert for this search

    Quality Manager • Galway, Connaught, IE