Posted 2w ago

Quality Engineer

@ SpiTrex CTE
Plymouth, Indiana, United States
OnsiteFull Time
Responsibilities:inspecting product, involving CAPA, analyzing data
Requirements Summary:3-5 years medical device quality experience; ISO 13485 knowledge; GD&T; CAPA; QA processes; high school diploma or GED preferred.
Technical Tools Mentioned:MS Office, GD&T, ISO 13485, Statistical Analysis
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Job Description

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