What are the responsibilities and job description for the Senior Quality Engineer position at Insight Global?
Our large medical supply client looking to bring on a Quality Engineer at their Hartland, WI manufacturing plant. This facility manufactures a variety of products including medical devices, drug products, and cosmetics. Products include, but are not limited to - shampoo, syringes, canisters, swabs, tablets, pre-surgical products, and disinfectant wipes. The Quality Engineer must be comfortable with a varying day to day and being able to shift priorities. They will be looking at investigations (CAPAs, NCRs, deviations) and involved in validations. They may own a few different product lines and need to learn / understand the process, support the validations, and manage day-to-day issues that come up. This position requires hands-on ownership of product lines. We are ideally looking for someone with a quality engineering background at a GMP manufacturing site who has experience with technical writing and non-conformance, CAPAS, deviations, and / or risk management activities.
Must Haves :
- 5 years’ experience of experience in quality engineering at a GMP manufacturing site
- Background in a regulated industry (pharma or medical devices)
- Experience working with non-conformance, CAPAS, deviations, and / or risk management activities
- Technical writing experience
- Knowledge of SAP
- Strong Microsoft Office skills (Excel, Word, Outlook, etc.)
- Strong communication and interpersonal skills – collaborating with different departments / divisions
- Comfortable working in a manufacturing environment
Nice to haves :