Senior Quality Engineer

CTE Solutions; Plymouth (IN); On-site; USD 95,000 - 130,000; Full time

Benefits offered by this job

Medical, Vision and Dental Insurance

Short-Term Disability

Life Insurance

401(k) - 50% company match

Paid vacation days

Paid holidays

Job summary

SpiTrex CTE in Indiana is seeking a senior Quality Engineer to lead quality initiatives across product development and manufacturing. You will support audits, regulatory compliance, and continuous improvement in a medical device environment.

You will develop procedures, analyze data, and mentor team members while collaborating with suppliers and cross-functional teams to uphold ISO 13485 and 21 CFR Part 820 standards.

Qualifications

• Bachelor's degree in Engineering or equivalent with 5+ years in quality engineering in medical devices.
• Strong understanding of ISO 13485 and 21 CFR Part 820 compliance.
• Experience leading audits and cross-functional teams.

Responsibilities

• Assist with customer and internal audits, Notified Body audits, and FDA inspections.
• Collaborate with supplier management including supplier performance and audits.
• Manage direct reports and develop quality control procedures.
• Monitor data to identify improvement opportunities and initiate projects.
• Lead cross-functional teams to resolve quality issues.
• Review and approve product and process changes.
• Develop procedures and work instructions as needed.
• Ensure adherence to medical device regulations and standards.
• Investigate and resolve customer complaints.

Skills

Quality engineering

Medical device regs

GD&T understanding

Statistical software

Leadership

Education

Bachelor's degree in Engineering

Tools

Statistical Software

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