Quality Engineer I - Sterilisation Validation

Medtronic Sterilisation Validation Engineer

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

Our Purpose

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.

A Day in the Life of:

• 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 with 0 years of experience required.
• Sterilisation Validation/Microbiology experience 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.

Benefits & Compensation

Medtronic offers a competitive salary and flexible benefits package. A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

About Medtronic

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people. We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.