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Quality Engineer @ Culvertool

Plymouth, IndianaOnsiteFull-time
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About this role

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

Skills

Quality

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