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Quality Manager

  • Division: Engineering
  • Contact Email: michelle.mcinerney@collinsmcnicholas.ie
  • Job Ref: 24067

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.

For more information and a confidential discussion on the role please contact Michelle Mc Inerney.

michelle.mcinerney@collinsmcnicholas.ie

091 706717