Quality Engineer

Build More Than a JobBuild a Career at SpiTrex CTE

At SpiTrex CTE, we invest in our people. Youll 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 CAPAs, 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