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Principal Quality Systems Engineer

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Location
San Francisco, CA
Job Type
Direct Hire
Date
Jun 11, 2019
Job ID
2669533

Principal Quality Systems Engineer


Part of the Quality Systems team. Role will sit in San Francisco office.   


THE COMPANY: 


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:


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 the company Quality Policy
  • Establishes and promotes a work environment that supports the Quality Policy and Quality System

PERSONAL AND PROFESSIONAL QUALIFICATIONS:



  • 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


PERKS & BENEFITS:



  • A place to grow your career. We’ll help you set big goals - and exceed them
  • Work with talented, committed and supportive teammates
  • Equity and performance bonuses. Every employee is a stakeholder in our success
  • Boundless snacks and drinks
  • Cell phone subsidy, commuter benefits and discounts on their products
  • Excellent medical, dental and vision benefits
  • Work in the heart of San Francisco, one of the world’s greatest cities

My client is proud to be an equal opportunity employer and is committed to creating a diverse and inclusive work environment for all employees and job applicants, without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. We will consider for employment qualified applicants with arrest and conviction records, pursuant to the San Francisco Fair Chance Ordinance. They also complies with the employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work clients’ in the US.