About Us

PerkinElmer is a global technology leader driving growth and initiative in the Environmental and Human Health Science markets. The company is a leading force in the development, production, marketing, servicing, and supporting of laboratory instrumentation and ancillary services throughout the world.

We are seeking a Senior Quality Engineer based in Santa Clara, CA.

Position Overview

A senior level Quality Engineer supporting Quality Assurance and Product Quality for Medical Device products. In collaboration with the site cross functional process owners lead and execute Quality and Regulatory initiatives to assure product quality and process capabilities are achieved in compliance with defined requirements while achieving productivity and business needs.

Specific Responsibilities Include

   

  • Drive quality assurance initiatives to achieve product quality and reliability with focus on design, materials, equipment, and process capabilities
  • Guide and support functional owners to achieve effective use of risk management processes through the use of FMEA, to achieve product, and process design robustness
  • Work in conjunction with functional owners to achieve effective use of technical and design reviews for product and process designs
  • Establish and maintain necessary protocols to assure site validated state such as Fab (controlled manufacturing environment), Environment, Equipment and Process validation protocols
  • Lead and coach functional owners to achieve effective process validation results to meet regulatory requirements through the use of but not limited to validation protocol, execution, and reporting
  • Provide assistance as QA representative to functional owners in the qualification of materials, processes or products
  • Drive failure analysis to root cause and institute corrective and preventive actions
  • Review and approve Engineering Change Notices (CNs)
  • Review and approve Process Deviations (PDs) or proposed process changes
  • Develop, review and approve as necessary QA documents or records
  • Supporting member of the Quality Team
  • provide specific guidance and direction to general staff, department managers and functional owners
  • Support internal and external audits to ensure full compliance to ISO 13485 and FDA requirements
  • Provide cross functional support to other Quality Department functions
  • Manage projects to improve productivity through improvement of process capability, product yields and performance utilizing industry best practice process improvement tools and techniques

Desired Skills and Experience

See application page for details