Senior Quality Engineer

SpiTrex Orthopedics; Plymouth (IN); On-site; USD 80,000 - 110,000; Full time

Benefits offered by this job

Medical, Vision and Dental Insurance

Short-Term Disability

Life Insurance

401(k) - 50% company match (up to 10%)

Paid vacation days

Paid holidays

Job summary

SpiTrex CTE in Indiana is hiring a Quality Engineer to lead audits, develop and implement quality control procedures, and drive continuous improvement across product lines.

You will supervise direct reports, coordinate supplier audits, analyze data, review changes, and ensure compliance with ISO 13485 and 21 CFR Part 820. A BS in engineering and 5–7 years in medical device QA are preferred.

This role offers growth, a collaborative culture, and comprehensive benefits.

Qualifications

• B.S. in Engineering preferred or minimum of 5 years in Quality Engineering.
• 5-7 years of Medical Device experience in Quality setting preferred.
• Strong background in quality control and quality engineering functions.
• Understanding GD&T.
• Experience with Statistical Software and Gage Repeatability and Reproducibility.

Responsibilities

• Lead audits (internal, supplier, Notified Body) and ensure FDA readiness.
• Develop and implement quality control procedures and guidelines.
• Monitor data and identify areas for improvement; initiate quality improvement projects.
• Collaborate with cross-functional teams to resolve quality issues.
• Review product and process changes and ensure proper documentation.

Skills

Quality engineering

GD&T

Statistical software

Gage R&R

Leadership

Communication

Regulatory knowledge

Multi-project mgmt

Education

B.S. 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

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 complaintsConform 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