Contract position: A Sr. Quality Engineer is needed for a manufacturer of optics products in the Southborough, MA 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
- Lead or participate in the development of process and procedure development/changes. Applies statistical process control (SPC) methods to evaluate current processes and process changes.
- Develops 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.
- Provide support to metrology and preventive maintenance programs. Support validation and verification strategy for new and existing products and processes as assigned.
- Bachelor's degree in Engineering with at least 8 years of related experience, preferably in the medical device industry.
- Knowledge of basic mechanical testing and material properties. Knowledge of metrology. Background 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.