Contract position: A Senior Quality Engineer is needed for a manufacturer of optics products in the Brooklyn Park, MN area. This position will support new product development, procurement, manufacturing, and servicing processes representing the Quality Engineering discipline. No per diem available. No travel anticipated. Responsibilities for the Senior Quality Engineer
Requirements for the Senior Quality Engineer
- Complete assigned Quality Engineering tasks to schedule. Promote awareness of Quality and Regulatory requirements.
- Lead or participate in the development of process and procedure development/changes. Apply statistical process control (SPC) methods to evaluate current processes and process changes.
- Create new approaches to solve problems identified as part of the team. Assist in the implementation, compliance, and maintenance of standards (e.g., FDA, ISO13485) and OGA Quality policies and procedures.
- Bachelor's degree in Engineering or an equivalent field. At least 8 years of related experience, preferably in the medical device industry related to process and/or quality engineering.
- Knowledge of basic mechanical testing and material properties. Knowledge of metrology.
- Requires background and familiarity with U.S. FDA QSR, requirements including ISO 9001, MDD 93/42, ISO 13485-2003, and Canadian Medical Device requirements.
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.