Quality Engineer - Medical Devices

Job Description

Job Description

Are you looking to take your quality expertise to the next level while making a real impact in medical device manufacturing? We’re searching for a Quality Engineer to join our team and help ensure our products meet the highest standards for safety, compliance, and performance. This role is hands-on, engaging, and provides opportunities for growth, innovation, and leadership.

What You’ll Do

In this role, you’ll support the quality department objectives by performing technical activities to ensure goods and services meet customer requirements for quality, quantity, and timeliness . You will collaborate across teams to uphold compliance with ISO and FDA standards, optimize processes, and drive continuous improvement.

Essential Duties and Responsibilities :

Supervise and perform testing and inspection activities, including training inspectors or technicians.

Provide quality and reliability engineering support on product development projects in accordance with ISO and FDA requirements.

Review components, products, and processes to optimize inspection methods, sampling plans, and documentation.

Develop, document, and train employees on quality standards and control plans to ensure requirements are met during production.

Partner with production teams to support validation and qualification studies.

Create, modify, and implement quality systems and procedures for both internal and external use.

Analyze nonconforming conditions, determine root causes, and collaborate with process owners to implement corrective and preventative actions.

Summarize, report, and evaluate nonconformance trends and major causes.

Conduct measurement repeatability and reproducibility studies.

Perform internal audits of the quality system and verification activities.

Provide general quality support as directed by management.

What You Bring

Minimum Qualifications :

BS degree in Engineering or equivalent experience.

3–5 years of experience in Quality Engineering within the medical device industry.

Hands-on experience with ISO and FDA Quality Systems.

Strong understanding of ISO 13485 and FDA 21 CFR Part 820 cGMP standards.

Technical skills in disposable medical device testing, protocol development, analysis, report writing, and statistics (e.g., DOE, SPC).

Strong analytical and problem-solving abilities.

Preferred Qualifications :

Six Sigma Green Belt certification.

Experience with quality assessment and audits.

Why Join Us?

We value your time and effort. Any hours worked beyond the standard 40-hour workweek can be rewarded with additional pay or converted into extra PTO—giving you the flexibility to choose what works best for you.

Beyond your daily responsibilities, you’ll have opportunities to grow and engage through career fairs, industry conferences, special events, leadership development, and more.

If you’re passionate about quality, eager to contribute to meaningful work, and ready to grow in your career, we’d love to hear from you.

We value your time and effort—any hours worked beyond our standard 40-hour week can be rewarded as additional pay or converted into extra PTO, giving you the flexibility to choose what works best for you.

Your opportunities go beyond your day-to-day role, including career fairs, industry conferences, special events, interviews, and participation in leadership events and training.

Medical Murray is an equal opportunity employer.