Works with Operations, R&D and/or external customers to plan and execute identified Biocompatibility and Sterilisation activities. Supports key programs such as Biocompatibility assessments, sterilization validation and environmental monitoring. Responsible to monitor and implement changes to respective programs as improvements or updates are identified.
- Site SME for all Biocompatability activities, providing technical excellence in the field and selection of testing strategies and materials.
- Develop Sterilisation plans for products as required and Lead sterilisation validation for new products and related change control.
- Ensure compliance to all relevant regulations for sterilisation and microbiology which includes maintaining all quality systems and related documentation.
- Collaboratively work with external contract sterilization test facility and contract testing services.
- Support Operations and R&D Project Teams with respect to Biocompatability testing strategies and sterilization validation requirements.
- Management of process deviations, NCRs and CAPAs related to Biocompatability & Sterilisation Processes.
- Knowledgeable of the associated Quality System requirements and interpretation of same ISO/FDA/AAMI related to biocompatibility and sterilisation.
- Conduct supplier auditing as required as SME for sterilisation.
- Management of the site environmental monitoring program.
- Support external audits including notified body and FDA audits.
- Promote the awareness of regulatory and customer requirements throughout the organization.
- Level 8 Degree in Science/Engineering.
- Minimum of 5 year's experience in a quality engineering / sterilisation / microbiology role, preferably in the Medical Device sector.
- Familiarity with regulations and standards published by FDA, USP, AAMI, ANSI, ASTM, and ISO in the areas of biocompatibility & sterilisation.
- Knowledge of Microbiological and Environmental monitoring programs preferred.
- Supplier/Internal Auditing experience.
- Excellent planning and coordination skills plus verbal and written communication skills.
- Ability to work within a team environment to achieve agreed company goals.
- Ability to communicate effectively with all levels of the company.
- Ability to meet deadlines and follow through on assigned deliverables.
- Good understanding of ISO 13485 and FDA QSR quality standards.
- Attention to detail.
- Proficiency in use of desktop software applications such as MS Office
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