Senior QA Engineer – Medical Devices & Compliance

Regulatory Jobs; South Jordan (UT); On-site; USD 95,000 - 120,000; Full time

Benefits offered by this job

Healthcare benefits

Onsite medical clinic

Multiple shift options

Onsite cafeterias

Vacation and holidays

Job summary

Merit Medical is seeking a Quality Engineer to perform complex quality engineering tasks for specific product lines under guidance. You will lead failure investigations, risk analyses, and control of nonconforming materials while improving quality documentation and processes.

Responsibilities include evaluating engineering variables, approving ECNs, and supporting supplier quality audits. The role requires knowledge of 21 CFR 820 and ISO standards, with a focus on continuous improvement in a

Qualifications

• Education and/or experience equivalent to a Bachelor's Degree in Chemistry or related field with five years quality engineering experience.
• Strong interpersonal, organizational, and verbal and written communication skills.
• Working knowledge of medical device quality standards (21 CFR 820, ISO 13485, ISO14791).

Responsibilities

• Independently evaluates, selects, and applies standard engineering techniques.
• Investigates engineering variables and completes assignments with defined objectives.
• Reviews and generates ECNs to update verification/validation methods and tests.
• Participates in supplier quality audits and nonconformance reviews.
• Ensures containment of nonconforming product and updates quality systems as needed.

Skills

Interpersonal skills

Verbal and written communication

Teamwork

Analytical thinking

Education

Bachelor's degree in Chemistry or related field

Tools

21 CFR 820

ISO 13485

ISO14791

Six Sigma

Lean manufacturing

Job description

Merit Medical is seeking a Quality Engineer to perform complex quality engineering tasks for specific product lines under guidance. You will lead failure investigations, risk analyses, and control of nonconforming materials while improving quality documentation and processes.

Responsibilities include evaluating engineering variables, approving ECNs, and supporting supplier quality audits. The role requires knowledge of 21 CFR 820 and ISO standards, with a focus on continuous improvement in a