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Senior Quality Engineer

  • Job type: Permanent
  • Location: San Francisco, California
  • Salary: Negotiable
  • Job reference: 221321/002_1540907984
  • Sector: Quality, DSJ Global
  • Date posted: 30/10/2018

Senior Quality Engineer needed for Medical Device company in San Francisco

A growing Medical Device organization is looking for a Senior Quality Engineer to join their Quality Systems team. This individual will lead the implementation, management and continuous improvement of Quality Systems to map with Quality System Regulation, ISO 13485, in addition to any applicable Federal and State compliance requirements specifically to the product. They will be responsible for assisting in the development of a compliant Quality Systems program and quality documents, and for assuring that quality data generated and submitted to regulatory agencies are valid and correct.

If you are looking for an innovative, leadership position - This is the move for you!

Responsibilities:

  • Develop and acquire necessary tools and expertise to drive change control and risk management activities for quality assurance programs, policies, processes, procedures, and controls ensuring compliance to industry standards and strive for best in class quality system.

  • Drive, establish and support design compliance activities, post market surveillance and Quality System software validation activities.

  • Assure all products, processes and systems comply with the product development and change management policies, procedures, and specifications.

  • Review, analyze and report on quality related to process and product systems and guide development of disposition and corrective actions for recurring discrepancies.

  • Present performance metrics and status of critical issues to quality management.

  • Lead cross-functional problem-solving teams to drive process and product improvements; use of QA methodologies to manage and facilitate issue resolution including root cause investigations and the development, implementation, and monitoring of effective corrective and preventive actions.

  • Work with Management, Consultants, and Staff to develop practical solutions to achieve regulatory compliance and support quality process improvements.

  • Train Management and Staff on policies and procedures.

The ideal candidate will have the following skill set:

  • 5+ years of Quality Systems experience working in an FDA regulated industry: medical device, pharmaceuticals, or combination products.

  • Bachelor's Degree in Engineering (Quality, Mechanical or Electrical preferred) or Applied Sciences preferred.

  • Knowledge of quality problem-solving methods including, but not limited to, Complaints root-cause investigations, CAPA/SCAR, NCR, fishbone diagrams, FMEA, process capability analysis, hypothesis testing, DoE, SPC, Lean manufacturing, Six Sigma. Additionally, evidence of the application of these methods to solve complex problems in a design center/manufacturing environment.

  • Detail oriented, ability to effectively handle multiple priorities, flexibility to reorganize and reschedule work on short notice to meet tight deadlines, have a strong quality mindset, and enjoy working in a team environment.

  • Ability to make decisions and take accountability for those decisions, with limited information, in high-pressure time limited situations.

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