What are the responsibilities and job description for the Quality Engineer position at SpiTrex Orthopedics?
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?
1st Shift: Monday to Thursday, 6AM - 3PM; Friday, 6AM - 10AM
Essential Functions
High School Diploma or GED preferred
Experience
Minimum 3-5 years of Medical Device experience in Quality setting preferred
Benefits Include
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
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
- 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)
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