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Principal Quality Systems Engineer

San Francisco Metro Area, CA

Posted: 06/05/2019 Job Type: Engineering Job Number: JN -062019-25037


The Principal Quality Systems Engineer develops, establishes and maintains quality engineering methodologies, systems, and practices which meet FDA CFR 820/210/ISO 13485 regulatory, customer, and country requirements. Serves as a lead Quality Systems representative on the cross-functional teams to improve awareness, visibility, communication on quality management initiatives to support departmental, functional, and corporate quality systems goals and priorities. Provides focused quality systems and quality engineering support to stakeholders, quality process SMEs and process design teams.

  • Provides leadership role on championing departmental or cross-functional quality systems initiatives
  • Provides quality systems direction, coaching, and mentoring for engineering and technical team personnel
  • Proactively investigates, identifies, and implements best-in-class Quality Systems/Engineering procedures, practices and standard work
  • Mentor for technical quality systems guidance for identifying and resolving quality issues or to optimize development processes
  • Identifies and implements effective process control systems to support the development, qualification, and on-going development of products to meet or exceed internal and external requirements
  • Leads in the implementation of quality systems processes, process controls, and CAPA systems designed to meet or exceed internal and external requirements
  • Acts as an effective leader or team member in supporting quality disciplines, decisions, and practices
  • Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
  • Assures the development and execution of streamlined business systems which effectively identify and resolve quality issues
  • In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures
  • Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to our Quality Policy
  • Establishes and promotes a work environment that supports the Quality Policy and Quality System
  • 10-15+ years of industry experience in one or more of the following disciplines: Quality Systems, Product Realization or Design Quality Assurance
  • Ability to work with a multi-functional team to define requirements and suitable metrics for the performance of new products and process
  • Experienced professional with a complete understanding and wide application of principle, theories, and concepts in the field
  • Problem solving knowledge and experience
  • Experience working in an FDA CFR 820/ISO 13485 regulated environment
EDUCATION: BS or MS degree in Engineering or Applied Science
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