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Senior Supplier Quality Engineer, Capacity Expansion

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Location
San Francisco, CA
Job Type
Direct Hire
Date
Jun 16, 2019
Job ID
2669549

Senior Supplier Quality Engineer


San Francisco and Dallas


 Our client is an exceptional team with backgrounds in technology, healthcare, CPG and biotech, and growing rapidly to deliver on their mission. Looking to hire the world’s best scientists, engineers, designers, product managers, supply chain experts, customer service and business professionals.


ROLE AND RESPONSIBILITIES:


Seeking SENIOR SUPPLIER QUALITY ENGINEER to join our Quality Supply Chain-Capacity Expansion team. The Senior Supplier Quality Engineer develops, establishes and maintains quality engineering methodologies, systems, and practices which meet FDA, customer, and regulatory requirements. Serves as a Quality representative at our sites to improve awareness, visibility, communication on quality initiatives to support departmental, functional, site, divisional and corporate quality goals and priorities.  Provides focused quality engineering support within new product development, operational, or system/services support.



  • Provide leadership role on championing departmental or cross-functional engineering initiatives
  • Provide project direction, coaching, and mentoring for engineering and technical team personnel
  • Proactively investigate, identify, and implement best-in-class Quality Engineering practices
  • Mentor for technical guidance for identifying and resolving quality issues
  • Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements
  • Lead in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements
  • Act as an effective leader or team member in supporting quality disciplines, decisions, and practices
  • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
  • Assure the development and execution of streamlined business systems which effectively identify and resolve quality issues
  • Demonstrate a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures
  • Assure that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to Quality Policy
  • Establish and promote a work environment that supports the Quality Policy and Quality System
  • Position requires significant domestic and international travel up to 75%.

PERSONAL AND PROFESSIONAL QUALIFICATIONS:



  • 5+ years of industry experience in one or more of the following disciplines: Supplier Quality, Process Validation,  Process Operations, Product Engineering, Reliability and/or Qualification
  • 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 principles, theories, and concepts in the field
  • Problem solving knowledge and experience
  • Experience working in an FDA and ISO 1385 regulated environment
  • Experience working in high volume automation manufacturing is preferred.
  • Experience in establishing, qualifying and working with Controlled Environmental Rooms.

EDUCATION:  



  • BS or MS degree in Engineering or Applied Science
  • ASQ Certification preferred.
  • ISO 13485 Lead Auditor Certification preferred.