Experienced Quality Engineer (Design/Medical Device) – RTP/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 and knowledgeable Quality Engineer, with particular expertise in Design Phase Quality, to assume key role on its outstanding team.

This RTP-based company develops cutting edge surgical tools that are widely-embraced by the medical community.  It boasts a rich and expanding pipeline, and this Design Quality Engineer will be actively involved in the early stage development of new technologies. This is a critical role and company will pay excellent wage to attract and retain an excellent candidate.

Key things to note:

  • These are mechanical tools with an electronic/software component.  Similar exposure is strongly preferred.
  • This Engineer will provide Quality insight to the development of electromechanical designs focused on exploring next generation technologies and optimization of current systems.  Seek industrious and forward-thinking candidate with a keen Quality mindset.
  • This is a Quality team that develops congenial and productive relationships with coworkers, vendors, etc.  Seek technically-skilled Quality Engineer, with a positive energy and a collaborative work style.
  • The company operates under cGMP and ISO 13485 standards, and related exposure is required.

Specific duties:

  • Participates within the early concept phase design control process by assisting Development with understanding and defining customer needs and translating them into product requirements.
  • Drives risk management activities including creation and maintenance of risk management files by product.
  • Contributes to concept phase design verification and validation activities including definition and qualification of test methods, acceptance criteria and statistical principles.  Coordinates activities with external test labs.
  • Participate in the continuous improvement of the Quality Engineering System.
  • Contributes to cross-functional activities that support business goals
  • Participates in the review and assessment of competitor products, processes or trends that could impact business
  • Ensures compliance with Quality and Regulatory policies, procedures, and practices through appropriate communication, training, and education of sound Quality Assurance and Regulatory principles.

Ideal candidate will offer an Engineering degree (advanced degree preferred) and 4+ years of broad-based Quality experience in a medical device design setting.  Software design and validation exposure would be a valuable plus.

Other priorities include:

  • Understanding of design control, disciplined product development processes, Regulatory/Quality requirements
  • Working knowledge of common Quality tools (i.e. Cpk/Ppk, DOE, Quality Reporting, etc.).
  • Equipment and process validations experience
  • 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 brings ingenuity and initiative; 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.