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Manager, Quality Assurance Engineering

Scientific Search La Honda, CA

  • Posted: over a month ago
  • Full-Time
Job Description

Manager, Quality Assurance Engineering
Location is Palo Alto, CA

additional jobs can be found at www.ScientificSearch.com

Position Summary:

Lead and develop the Quality Assurance Engineering function.  Plan and manage activities concerned with the development, application and maintenance of quality standards for manufacturing processes, materials and products.  Manage and plan the activities of the quality engineering group, with the main objective of supporting Research & Development activities, optimizing product performance and controlling the manufacturing process.  Develop and implement strategies to integrate quality assurance into every aspect of company business system.

Core Job Responsibilities:

  • To provide support for ISO13485/ Quality System
  • Support Research & Development with Catheter development projects
  • Drive Risk Management (RM) activities and documentation including assess and implement new RM application
  • Responsible for ensuring adherence to all internal, external and appropriate regulatory requirements
  • Key member of the Quality Assurance Team
  • Support Operations in relevant continuous improvement activities
  • Day to day supervision and management of the Quality Assurance Engineering Team.  Manage and develop the team through involvement, delegation, and regular reviews of performance
  • Support of Key quality systems elements relating to direct production support such as the Non- Conformance System, Incident Reporting System and customer complaint analysis
  • Management of Sustaining Quality Engineering activities
  • Driving key changes and improvements in the Quality Assurance and Control Systems
  • Prepare and maintain documentation in compliance with appropriate regulatory requirements
  • Supporting key changes and improvements in manufacturing relating to product quality
  • Good Manufacturing Practices (GMP) oversight and compliance of Production and Quality Engineering activities
  • Lead/support internal and external Quality Management System and technical audit activities
  • Drive routine monitoring and compliance activities around EO & E-Beam sterilization processes
  • Co-ordinate product and packaging shelf-life extension activities
  • Drive quality activities for design/product related CAPA activities

Requirements:

  • Bachelor’s degree in Engineering; 7+ years of experience in the medical device industry; a minimum of five years of experience in quality engineering function and 3-5 years supervisory experience; or equivalent combination of education and experience required
  • ASQ CQE certification preferred
  • Experience in Process Optimization and Variability Reduction/Cost Reduction Projects or similar 
  • Experience with new product development preferred.  Regulatory knowledge specific to the FDA Quality System Regulations, ISO9001/ISO13485, and the Medical Device Directive (MDD) required
  • Experience with ISO 14971, IEC 60601, IEC 60825, IEC 62304, IEC 62366
  • A working knowledge of FDA requirements
  • Experience in process validation, Sterilization and working in a clean room environment would be advantageous
  • Proven ability of working in a cross-functional team environment
  • Excellent interpersonal, communication skills and high level of computer literacy
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Company Description
Are you looking for a place where people really enjoy coming to work? Leading Biotech/Engineering firm developing high tech biological products. Great place to work. The company is proud of its employee retention rate.

Scientific Search

Are you looking for a place where people really enjoy coming to work? Leading Biotech/Engineering firm developing high tech biological products. Great place to work. The company is proud of its employee retention rate.

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La Honda, CA
94020 USA

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Food

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