Quality Systems Engineer (Design/Change Management) – Medical Device/Top $$

Job Type: 
Quality Assurance and Quality Control
Employment Category: 
Direct Hire

Our client, one of the fastest growing medical device companies in the country, is actively recruiting for a very sharp Quality Engineer to assume key role on its outstanding team. 

This company is developing cutting edge robotic surgical tools, and boasts a rich and expanding pipeline of next-generation products.  This Quality Systems Engineer will be actively involved in the development of new technologies, with particular focus on configuration and change management.

Company will pay excellent wage to attract and retain a star.

Key things to note:

  • These are mechanical tools with an electronic/software component.  Similar exposure is preferred.
  • This Engineer will work with the Design team to help ensure the successful release of components and devices as well as ensure quality-driven procedures are used in the design, development, and commercialization of its products.   Seek industrious and forward-thinking candidate with a keen Quality mindset.
  • Role will involve application of statistical methodologies used to solve complex problems.  Practical experience using statistical software (Minitab, SAS, etc) would be valuable.
  • This is a Quality team that develops congenial and productive relationships with coworkers, vendors, etc.  Seek technically-skilled Quality Engineer, with positive energy and a collaborative work style.
  • This is an emerging business in which policies and practices are still being developed and enhanced.  Successful candidate will bring ingenuity, flexibility, and drive.

This Quality Systems Engineer will work closely with the Design/Development teams to ensure that Design Changes meet Quality standards and that related documentation is flawless. 

Specific duties will include:

  • Interface with multiple departments (engineering / clinical / operations / manufacturing) to ensure document / change management activities occur in a coordinated and timely fashion
  • Coordinate formal review and approval of engineering document deliverables (documents, drawings, user materials, etc.)
  • Process and release Engineering Change Orders using company's Product Lifecycle software ensuring all impacted systems, processes and documents are concurrently updated and managed
  • Apply statistical methodologies to solve complex problems
  • Create and manage DHF and DMRs for products to be released under oversight by regulatory agencies around the world
  • Ensure overall documentation quality through proofreading grammar, format, consistency, and completeness
  • Participate in the continuous improvement of the company's quality management system.
  • Contributes to cross-functional activities that support business goals

Ideal candidate will offer an Engineering degree and 3+ years of broad-based Quality experience in a medical device design setting.  Change Management focus will be important. 

Other priorities include:

  • Solid understanding of design control, disciplined product development processes and Regulatory/Quality requirements
  • Familiarity with applying statistical methodologies to Quality efforts, including using statistical software (Minitab, SAS, etc.)
  • Working knowledge of common Quality tools (i.e. Cpk/Ppk, DOE, Quality Reporting, etc.).
  • Knowledge of relevant standards including ISO13485, 21 CFR Part 820 and ISO 14971
  • Knowledge of engineering performance enhancement tools in the area of Design for Six Sigma preferred
  • ASQ Certification desirable (CQE, CBA, CQM, CRE, etc.)
  • Longevity and impact in previous roles

Finally, and critically, we seek a hands-on, make-things-happen worker; someone who sees a need and fills it; one who works exceedingly well in a collaborative, dynamic and empowered setting. 

This is a very exciting time at a very exciting company.   We seek a contributor who will thrive.

This is an immediate need.  Please forward Word resume for prompt consideration.  Local candidates only.