Quality Engineer Job Opening

FlexDex Surgical, a medical device startup based in the Ann Arbor (MI) area, is working to transform minimally invasive surgery world-wide. FlexDex’s line of surgical instruments are based on an elegant mechanical design that offers finesse, dexterity, and instinctive control so far seen only in multi-million dollar robotic solutions. The company’s mission is to globally democratize minimally invasive surgical procedures that are currently too complicated or too expensive.

Several video demonstrations are posted on the company’s website: www.flexdex.com/videos.

To realize its vision, FlexDex is looking for a Quality Engineer to join the team!

Quality Engineer uses Quality Engineering principles, tools, and techniques to develop, optimize, and support systems and processes that are aligned with the overall strategy of FlexDex Inc. The FlexDex Quality Engineer II is responsible for design controls and process controls related to FlexDex development and sustaining engineering.

Furthermore, this role is also responsible for the Product Surveillance process including investigation, follow-up, and reporting.

This position reports to the Manager of Quality and Regulatory.

Main Responsibilities:

  • Support, consult, train, and lead quality improvement projects throughout the life-cycle of FlexDex products, including product design, development, product surveillance, and process improvements.
  • Utilize Quality Engineering tools and techniques to establish sampling plans, develop quality plans, manage risk through risk analysis tools, design and process verification and validation, conduct process audits and assist in system audits.
  • Provide statistical support and use statistical means for development, validation, and improvement, as needed. This includes possible use of DOE, Pareto, ANOVA, SPC, capability analysis, etc. Summarizes, analyses, and draws conclusions based on the objective evidence.
  • Investigate nonconforming material and assist with the determination of root-cause
  • Investigate, implement, and verify Corrective or Preventive Actions as dictated by Quality Management.
  • Manage the Product Surveillance program. Responsible for timely investigation and reporting. Works with other functions to identify root-cause, adequate containment, and appropriate correction, where appropriate.

Educational Requirements:

A bachelor’s degree (B.S.) in engineering, science, mathematics, or statistics is preferred. Equivalent combination of education and experience is acceptable.

Additional Skill Requirements:

  • Two years of related experience is preferred
  • Experience in medical device or other regulated industry is a plus
  • The ability to prioritize and manage multiple projects with no negative impacts to business
  • Strong communication skills, both verbal and written
  • The ability to work with, and lead, a wide variety of people effectively and efficiently.

Training Requirements:

  • ASQ Certifications such as CQE, CQA, SSGB, SSBB, are desired
  • Quality systems and process audit certification and/or training is desired

If you fit well to the Quality Engineer opening, send your resume, cover letter and any work example/references to Jeff Flint. at jeff.flint@flexdexsurgical.com with the subject “QUALITY ENGINEER JOB OPENING


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