Senior Quality Engineer - Medical Devices, Growth & Flex

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

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.