Description:
At our Sterilisation Validation Department in Medtronic, plc, we focus on product quality excellence and providing exemplary service to the businesses & operating units we support. Our Sterilisation Quality Engineers anticipate and respond to
changing sterility requirements, provide strategic leadership to influence the
global sterility environment to benefit the patients we serve and are directly
involved in building the organisation in support of Sterility Assurance assessments for New Product Development and site transfers.
- Support routine Sterility Assurance activities e.g GMP, Standards Compliance, Cleanroom Risk Assessment, Limits review, Dose Audit activity, Cycle Requalification, Supplier Change control etc.
- Support Sterility Assurance activities for new products and change control, developing strong partnering relationships with these groups, at both manufacturing and design sites.
- Participate in root cause investigations and continuous improvement in day-to-day activity, initiating appropriate corrective actions and following through to implementation.
- Support cross functional teams in design protocols to ensure that new products/product changes are adequately evaluated/tested to guarantee compliance to all regulatory standards.
- Deliver on projects assigned and works with other stakeholders to achieve desired results within defined timeframes.
- Support your projects in internal and external audits and in submission preparation, addressing any questions regarding these submissions.
- Perform calculations, technical and record keeping duties in conformance with company and regulatory policies and standards to meet quality and accuracy requirements.
- Review systems and processes for optimisation and troubleshooting.
- Adhere to all relevant site wide procedures and practices for Safety & GMP.
Key Skills & Experience
- Minimum Level 7 degree in a relevant technical discipline e.g. Science or Engineering.
- 1-2 years’ experience with Sterilisation Validation/Microbiology is desirable.
- Excellent understanding of GMP and documentation required.
- Dynamic team player with good communication skills.
- Can work effectively and proactively as an individual or on cross functional teams.