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Senior Quality Engineer

2 months ago

Lafayette, United States Redbock - an NES Fircroft company Full time

Sr. Quality Engineer (2 year contract // Lafayette, CO):

Hybrid, 3 days on site minimum


A leading Medical Device company is seeking TWO Sr. Qualtiy Engineer consultants to join their Advanced Surgical Technologies team for a 2yr contract, on-site in Lafayette, CO.


Candidates must be able to work W2 without H1B sponsorship. We are unable to work C2C.


Top technical skills:

Advanced Understanding of IQ, OQ, PQ

  1. Advanced Understanding of GD&T
  2. Production Part Approval Process Experience
  3. Injection Molding experience

Experience using statistical techniques like process capability


Education Required: Bachelor’s Degree in Mechanical Engineering or Similar Engineering Degree

Years’ Experience Required: Minimum of 4 years of relevant experience

Description:

Help streamline and speed our time to market and build quality in at every step. You will be a member of the Released Product Engineering team that supports the design, development, and maintenance of innovative, new medical device products, as well as commercially released products within the Advanced Surgical Technologies business. You can apply advanced technical concepts to complex problems throughout the product life cycle.

In this role, you will work as part of a team, providing technical support on New Product Development and Sustaining Project Initiatives, ensuring medical devices are designed with the utmost regards to safety, reliability and quality. You will be responsible for reviewing supplier documentation including First Article Inspection Reports and OQ/PQ documentation ensuring parts meet specification and applying statistical techniques as necessary. Assisting with CAD and print updates for new component supplier qualifications with help from the Released Product Engineering team.

Duties:

Ensures that suppliers deliver quality parts, materials, and services.

  • Qualifies suppliers according to company standards
  • Monitors parts from acquisition through the manufacturing cycle and communicates and resolves supplier-related problems as they occur.
  • Generates 3D models and prints with a strong understanding of GD&T fundamentals
  • Evaluates FAI, OQ, and PQ data associated with a product par approval process and applies statistical techniques as necessary.
  • Collaborates with Component Engineers to develop and deliver the Product Acceptance Sampling Strategy and Control Plans for new components.

Must Haves:

  • Bachelor’s degree and a minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years of relevant experience.
  • Product Part Approval Process Experience
  • Understanding of IQ, OQ, PQ
  • Molding Experience
  • Understanding of GD&T
  • Experience using statistical techniques like process capability

Nice to Have:

  • 3D CAD experience
  • Degree in Engineering or Scientific discipline
  • Experience in the medical device industry.
  • Excellent analytical, organizational, and communication skills. Strong ability to work with multidisciplinary and global teams.
  • High tolerance for change, and ability to multi-task continuously.
  • Strong negotiation, conflict management, and influence management skills.