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Culver Tool And Engineering

7 jobs near Columbus, OH

Senior Quality Engineer

Culver Tool and Engineering LLC

Plymouth, IN • On-site

$80K - $109K/yr

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Posted 16 days ago

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:
  • Assisting with Customer Audits, Internal Audits, Notified Body Audits, and FDA Inspections
  • Assisting with Supplier Management (including but not limited to supplier performance review, and supplier audits)
  • Managing Direct Reports
  • Developing and implementing quality control procedures and guidelines
  • Monitoring and analyzing data to identify areas for improvement
  • Initiate quality improvement projects
  • Collaborate with cross-functional teams to resolve quality issues
  • Conducting audits on products and processes
  • Providing guidance to other team members
  • Investigating and resolving customer complaints
  • Conform to ISO13485, 21 CFR Part 820, and medical device industry requirements
  • Reviewing and approving product and process changes
  • Developing procedures and work instructions as needed
  • Other work-related tasks as assigned

Competency:
  • Strong background in quality control and quality engineering functions
  • Understanding GD&T
  • Experience with Statistical Software
  • Experience with Gage Repeatability and Reproducibility
  • Excellent communication skills
  • Excellent leadership skills
  • Detail-oriented
  • Strong analytical and problem-solving skills
  • Ability to manage multiple projects simultaneously
  • Strong understanding of medical device regulations

Educational Requirements:
B.S. in Engineering field preferred or minimum of 5 years in Quality Engineering role
Experience:
5-7 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

Apply