Contract position: A Sr. Quality Engineer is needed for a manufacturer of optics products in the Southborough, MA area. This position will work with external manufacturers and suppliers providing finished products, services, components, and sub-assemblies to ensure compliance with company policies, procedures, and medical device regulations. No per diem available. No travel required.Responsibilities for the Senior Quality Engineer
Requirements for the Senior Quality Engineer
- Lead supplier quality management for legacy products and support of new products under development per OSTA new product development (NPD) process.
- Lead corrective & preventive actions (CAPA's), supplier corrective action requests (SCAR's), and supplier notifications only (SNO's) to resolution, including monitoring, analyzing, and reporting on supplier performance data and metrics.
- Collaborate and approve supplier sourced component and subassembly specifications and/or drawings.
- Bachelor's degree in Engineering and at least 5 years of process quality engineering in Medical Device Industry.
- Prefer experience with an emphasis on Supplier Quality Management within an FDA-regulated medical device manufacturing environment.
- Proficient with statistics, sampling strategies, design of experiments, process capability, including statistical software tools such as Minitab.
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.