Strong manufacturing company located in the south shore area of Massachusetts is in search of a Quality Engineer to join their team.
Great company culture and environment.
Primary Duties and Responsibilities:Work with engineering 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
Skills/Qualifications Needed:Experience as a Quality Engineer in a manufacturing environment.
Knowledge of ISO1348:16 and 21 CFR Part 820 Medical Device Requirements.Knowledge of PFMEA, Process Control Plans, Process Maps, other Engineering and Quality related processes.Knowledge of Validation (IQ, OQ, PQ)Computer skills: Word, Excel, PowerPoint, Minitab, etc.
4-Year College Degree; preferably in engineering or related.Ability to travel globally as needed to other AAP, supplier, and customer locations.Minimum 8-12 years' related experience in a manufacturing environment.Ability to travel as needed to other AAP, supplier, and customer locations
Desired Skills:Lead auditor training to ISO13485:16 or ISO9001:15.Highly organized with excellent verbal and written skills, self-motivated.Understanding of REACH, ROHS, and Conflict Materials