Senior QA Engineer – Medical Devices, Risk & Compliance

Merit Medical Systems; South Jordan (UT); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Medical/Dental Insurance

Onsite Clinic

401(k) Plan

Paid Holidays

Job summary

Merit Medical Systems in Utah is seeking a Senior Quality Assurance Engineer I to perform routine and complex quality engineering work for product lines. The role involves risk management, ECN review, and supplier quality oversight to ensure compliance with medical device standards.

The position requires knowledge of 21 CFR 820, ISO 13485, ISO 14791 and related regulations, along with mentoring responsibilities and potential involvement in design/development activities.

Qualifications

• Education and/or experience equivalent to a Bachelor's Degree in Engineering or related field with six years of quality engineering experience.
• Strong interpersonal, organizational, and verbal and written communication skills.
• Working knowledge of 21 CFR 820, ISO 13485, ISO14791 and other medical device standards.
• Experience with statistics, quality control and manufacturing tools such as Six Sigma and lean.

Responsibilities

• Conduct routine and complex quality engineering work for specific product lines.
• Lead risk management activities and document results.
• Review and generate ECNs to update verification, validation, and inspection methods.
• Mentor Quality Auditors and Engineers to satisfy quality objectives.
• Evaluate supplier quality and perform supplier audits as required.
• Ensure containment of nonconforming product to prevent unintended use.
• Participate in design and development activities.

Skills

Communication

Teamwork

Regulatory knowledge

Statistics

Six Sigma

Lean manufacturing

ISO 13485

Education

Bachelor's degree in Engineering

Tools

MasterControl

SmartCAPA

Oracle

Crystal Reports

Job description

Merit Medical Systems in Utah is seeking a Senior Quality Assurance Engineer I to perform routine and complex quality engineering work for product lines. The role involves risk management, ECN review, and supplier quality oversight to ensure compliance with medical device standards.

The position requires knowledge of 21 CFR 820, ISO 13485, ISO 14791 and related regulations, along with mentoring responsibilities and potential involvement in design/development activities.