Senior Quality Engineer

Job Description

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