Senior Quality Engineer

  • location: Southborough, MA
  • type: Contract
  • salary: $42.18 - $44.72 per hour
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job description

Senior Quality Engineer

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
  • 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.
Requirements for the Senior Quality Engineer

  • 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.
Benefits

  • 401K
  • Health Insurance
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.

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