Quality Engineer

CTE Solutions•Plymouth, IN

4d•Onsite

About The Position

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

Requirements

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

Responsibilities

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