Vacancy expired!
- Provide support to the overall quality organization and handle customer requirements, change notification, CAPA, and MRB
- Collaborate with engineering team to develop inspection planning and documentation packages for customers
- Work with customers regarding nonconformance, quality alerts, and CAPA (problem solve)
- Execute First Article Inspections (FAI), CPK Studies, and GR&R
- Bachelor’s degree or equivalent, preferably in Engineering or related field
- At least 5 years of Quality Engineer experience in a manufacturing environment
- Knowledge of PFMEA, Process Control Plans, Process Maps, other Engineering and Quality related processes
- Knowledge of ISO1348:16 and 21 CFR Part 820 Medical Device Requirements
- Familiarity with Validation (IQ, OQ, PQ)
- Experience with MS Word, Excel, PowerPoint, Minitab, etc.
- Extremely organized with outstanding written and verbal communication skills
- Ability to travel internationally (post-COVID19) as needed
- Understanding of REACH, ROHS, and Conflict Materials a plus
- Lead auditor training to ISO13485:16 or ISO9001:15 a plus
Vacancy expired!