Senior Quality Engineer

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