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Sr. Quality Engineer

  • Andover, MA
  • Direct Hire
  • Job ID: CA168-2690532

$130000 to $150000 Per Year

SR. QUALITY ENGINEER / MEDICAL DEVICE 

Andover, MA 

The Senior Staff Quality Engineer is accountable for supporting new product development and product maintenance through the application of quality engineering skills for highly complex medical devices. This person will handle projects and tasks, from product inception through product launch and maintenance and play an active role in the processes to ensure products meet quality standards consistent with both Corporate and unit policies, while meeting all design control and other regulatory requirements.  This position develops highly advanced, new applications resulting in new products.  Decisions or recommendations would normally result in the achievement of goals critical to the major objectives of the company and would greatly enhance the image of the company’s quality technological capabilities.

  • The Senior Staff Quality Engineer is accountable for supporting new product development and product maintenance through the application of quality engineering skills for highly complex medical devices. This person will handle projects and tasks, from product inception through product launch and maintenance and play an active role in the processes to ensure products meet quality standards consistent with both Corporate and unit policies, while meeting all design control and other regulatory requirements.  This position develops highly advanced, new applications resulting in new products.  Decisions or recommendations would normally result in the achievement of goals critical to the major objectives of the company and would greatly enhance the image of the company’s quality technological capabilities. Develops quality strategy for large-scale, highly challenging programs with outstanding initiative and innovation
  • Contributes to long-range business strategies, choosing disciplines and methods appropriate to the work content and context.
  • Often acts independently on issue resolution, projects and other assignments.  Works under consultative direction toward predetermined long-range, business strategies in creative and effective ways
  • Exercises independent judgment in developing methods, techniques and evaluation criteria for obtaining results on new assignments
  • Provides consultation, guidance and work direction to colleagues and management and uses judgment to influence within and across functions to drive impact on the business/function
  • Provides critical direction and oversight to external designers, developers and manufacturers
  • Leads and mentors other quality professionals on complex projects and provides mentoring / coaching for application of technical principles, theories, concepts and quality tools and systems.
  • Leads cross functional teams through design control activities throughout the structured development process.
  • Develops advanced quality methods and guides their application into development of a final product, process or business opportunity.
  • Primary core team member/extended team member for complex design control / process control projects.
  • Serves as a change agent and advocate of quality culture
  • Serves as  Subject Matter Expert in the areas of design control and risk management and oversees completion and is accountable for Design Control requirements 
  • Ensures appropriate completion of all test method validations, software validations, and supplier qualification
  • Develops and initiates Post Market Surveillance plan

EXPERIENCE & EDUCATION:

  • B.S. degree, in a scientific, technical or engineering discipline.  Master in business or scientific discipline preferred.
  • ASQ Certified Quality Engineer, Six Sigma Black Belt or equivalent experience (preferred).
  • A minimum of 15 years progressive experience in Quality within an FDA-regulated industry.

KNOWLEDGE, SKILLS AND ABILITIES:

  • Extensive knowledge of applicable regulatory requirements.
  • Expert in Design Controls
  • Class II / III medical device experience.  Strong understanding and application of six sigma methodology preferred.  Ability to conduct internal / external Quality Systems audit. 
  • Training in design of experiments and statistics.  Comprehensive knowledge of Quality System standards and regulations including 21 CFR 803 & 820, and ISO 13485 / ISO 14971
  • Knowledge and experience in manufacturing, project management and engineering.
  • Must possess excellent oral and written communication skills, and proven supervisory/leadership capability.
  • Demonstrated ability to understand and communicate complex technical, statistical and compliance subject matter
  • Ability to manage and prioritize multiple activities with varying business, compliance and customer drivers.
  • Ability to lead and mentor quality engineers as well as other cross-functional core team members.
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