2022-07-29 11:26:48

Quality Assurance Manager

CVMarket.lt klientas

Job Description

  • Provide leadership and development for the QA team e.g. annual goal setting, Development and succession planning, team development, training and overall Quality function planning in Continence Care (CC) businesses.
  • Quality System:  manage the CAPA process in CC, internal and external audits and compliance to Quality system requirements
  • Customer Interactions: lead and manage customer complaint investigations and participate in customer visits as needed
  • Provide leadership in change and risk management
  • Provide direct leadership to the overall CC plant operations as a member of the CC plant leadership team
  • Provide leadership in implementing continuous Quality improvement projects
  • Lead the efforts to ensure clean room is designed, built, and operating to specifications

Requirements

  • 3 to 7 years’ experience in Medical Device/Pharma Industry in quality leadership role
  • Experience/knowledge of: Cleanroom Validation, Problem Solving, Root Cause Analysis, Audit Management, People management, and Process Validation.
  • Knowledge of ISO 13485, EU MDR, and FDA 820.30 requirements for Medical Devices
  • Sterile product manufacturing of medical devices or pharmaceuticals is highly desired
  • Proficient English skills
  • Willingness to travel for work assignments (2 to 3 weeks at a time each month)

Company offers

  • Professional development and career opportunities in new established manufacturing facility in Kaunas
  • Extensive training in other Hollister manufacturing facility abroad
  • Opportunity to become a part of a reputable company and join their unique culture
  • Attractive remuneration package

Only successful candidates will be notified. Confidentiality is guaranteed.