Quality Engineer

Build More Than a Job—Build a Career at SpiTrex CTE

At SpiTrex CTE, we invest in our people. You’ll find opportunities to grow, real flexibility, and a culture that values balance, development, and teamwork.

Why join CTE?

• Career Growth: Ongoing training and development through Bamboo Path Track & WorkForge


• Flexibility: Flextime options that support real life


• Culture: Team events, Donut Fridays, food trucks, and more


• Rewards: Referral bonuses, quarterly bonuses, and a 401(k) with 50% company match (up to 10%)


• Benefits: No-cost vision, life, and short-term disability; dental & medical with HSA or PPO options

Ready to grow with a company that values you? Join SpiTrex CTE.

 1st Shift: Monday to Thursday, 6AM - 3PM; Friday, 6AM - 10AM

Essential Functions:

• Facilitate standardized inspection and sample size methodology based on risk, process capability.


• New product involvement


• Inspection reduction based on process, production, or feature inspection issues for existing product


• Interact with In-process Inspection and Final Inspection, issue identification and resolution.


• MRB member, determine conformity of suspect parts


• Identifying failure modes and enacting countermeasures


• Audit quality processes and inspection methods


• Involved in CAPA’s, Quality Alerts, Retraining and data collection as needed


• Oversight of CMM programming schedule as directed


• Participate in project management as needed


• Conform to ISO13485, 21 CFR Part 820, and medical device industry requirements


• Other work-related tasks as assigned

Competency:

• Mastery in Process Capability, lean inspection methodology


• Strong emphasis on understanding of GD+T


• Ability to comply with Quality System requirements


• Strong Understanding of statistical analysis


• Problem-Solving prowess


• Must be respectful and display a positive attitude


• Working knowledge of ISO 13485


• Strong computer skills (MS Office)

Educational Requirements: 

High School Diploma or GED preferred

Experience:

Minimum 3-5 years of Medical Device experience in Quality setting preferred

Benefits Include:

• Medical, Vision and Dental Insurance
  


• Short-Term Disability
  


• Life Insurance
  


• 401(k) - 50% company match (up to 10% contribution)
  


• Paid vacation days
  


• Paid holidays