Job Detail

Location Dublin
Salary Negotiable
Role Type Permanent
Contact Clara Burke

Senior Quality Engineer – Biocompatibility and Sterilization

Job ID: JOB-11567
Senior Quality Engineer – Biocompatibility and Sterilization

My client is searching for a Senior Quality Engineer – Biocompatibility and Sterilization to join their team on a permanent basis at their Global Medical Device Engineering facility in North Dublin.

Job Description

The Senior Quality Engineer – Biocompatibility and Sterilization is a subject matter expert (SME) in the areas of biocompatibility and sterilization of medical devices. The primary goal of the role is to ensure continued compliance of the medical devices to regulatory standards. The incumbent has overall authority over strategy, assessment of changes and determination of validation and testing requirements including establishing relationships with external test houses or service providers to complete necessary studies. An important element of this position is to liaise with Contract Manufacturing Organizations (CMO), contract laboratories and service providers for matters arising that may impact device microbiology, sterilization and biocompatibility including investigation of any non-conformances or deviations. The role is part of the design quality team reporting to the Device Quality Manager.

Essential Functions

  • Develop biocompatibility and sterilization strategy and plan for new devices and processes in compliance with existing medical device standards and regulations (ISO 10993-1, ISO 18562, ISO 11135 etc)
  • Liaise with stakeholders across sites to assess microbiology and biocompatibility requirements for new materials and parts being qualified
  • Ensure the medical device QMS is compliant to the most current versions of ISO 11135, ISO 10993 and ISO 18562 in addition to other applicable regulatory standards by conducting gap assessments where necessary and updating the relevant procedures
  • Lead sterilization and biocompatibility assessments following process and product changes. Participate in Change Control Board (CCB) meetings to provide input on potential changes.
  • Lead Global Device Engineering (GDE) department projects as SME in the areas of biocompatibility and sterilization : generate plans, protocols and write summary reports in liaison with the cross-functional team and external test laboratories
  • Conduct validation and revalidation of the sterilization process in collaboration with service providers
  • Conduct assessments to determine device cleaning and disinfection (for reprocessed devices) requirements when necessary and coordinate testing with external test houses
  • Complete sterilization annual assessments to evaluate the overall state of the sterilization process and the necessity for revalidation as required by ISO 11135
  • Perform audits of sterilization facilities and biocompatibility / microbiology test laboratories
  • Coordinate routine laboratory testing of devices including Cytotoxicity, LAL, Particulate and Bioburden tests

Education / Experience / Skills:

  • Bachelors degree in a relevant science subject
  • 5 years’ experience in the medical device industry as a biocompatibility and sterilization expert
  • Experience in applying ISO 10993 and ISO 11135. Knowledge of pneumatic systems and ISO 18562 is desirable.
  • Understanding of medical device standards and regulations in the areas of microbiology (including microbial barrier, packaging integrity, shelf life) and biocompatibility: FDA guidances, GMP, ISO 11607, ISO 10993, ISO 11135, EU MDR, ISO 13485
  • Experience establishing relationships with test labs and coordinating testing
  • Lead auditor certification and / or experience performing audits
  • Ability to apply knowledge and experience to complex device platforms
  • Good organizational, communication and interpersonal skills
  • Experience working with a cross-functional and multi-disciplinary team

For further information on this Senior Quality Engineer role in Dublin please contact Clara Burke on 086 816 8273/

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Clara Burke


Senior Quality Engineer – Biocompatibility and Sterilization

Clara Burke

Role Type Permanent
Contact Clara Burke
mobile +353 86 816 82 73
linkedIn profile click here

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