Your Job
As a Quality Engineer you will ensure compliance with the Quality management systems in place (ISO 13485/15378/14001/ FDA 21CFR Part 820) and other relevant standards. You will carry out duties in accordance with Quality, Environmental Health and Safety policies of PMLK and GMP and contribute to the achievement of the company goals and KPI’s, including analysis of data for continual improvement.

WHO WE ARE

As a Molex company, Phillips-Medisize mobilizes and deploys specialized capabilities and services across highly regulated industries, including health care, regulated consumer, automotive and defense. We design, develop and create innovative and life-changing medical technologies for millions of people around the globe.
At Koch, employees are empowered to do what they do best to make life better. Learn how our business philosophy helps employees unleash their potential while creating value for themselves and the company.
Additionally, everyone has individual work and personal needs. We seek to enable the best work environment that helps you and the business work together to produce superior results.

LI-JO

• Batch review and product release of sterile and non-sterile product
• Non-Conformance investigations (both Internal and External).
• CAPA management
• Documentation of Vendor notified changes
• Liaise with NPI department in relation to component set up and validation activities and with vendors and customers in relation to Quality related matters.
• Managing and controlling outsourced sterilization and laboratory activities.
• Management of Sterilisation revalidation (ETO and GAMMA)
• Management of Environmental results including data trending and reporting
• Active participation in the quality culture, CIP and recognition programs.