Senior Quality Assurance Engineer – Medical Devices

Regulatory Jobs; South Jordan (UT); On-site; USD 80,000 - 110,000; Full time

Benefits offered by this job

Shift options

Medical & Dental

Onsite clinics

Paid holidays

401K

Job summary

Merit Medical is seeking a Quality Engineer in Utah to perform complex quality engineering tasks across product lines under supervision. Responsibilities include risk analysis, QA documentation, ECNs, and supplier quality oversight.

Qualified candidates will have a Bachelor’s in chemistry or related field, 5 years of quality experience, and strong knowledge of 21 CFR 820 and ISO standards. This role offers multiple shifts and onsite work in Utah, with comprehensive benefits.

Qualifications

• Bachelor’s degree in a chemistry-related field with five years quality engineering experience.
• Strong knowledge of 21 CFR 820, ISO 13485, ISO14791, and related medical device standards.
• Proven ability to work in a team and conduct risk management activities.

Responsibilities

• Conduct failure investigations and determine disposition of nonconforming materials.
• Review and generate validation, verification, and inspection methods and ECNs.
• Lead CAPAs and drive corrective actions to maintain QMS effectiveness.
• Perform risk analysis, data collection, trending, and presentation of key metrics.
• Evaluate supplier quality, perform audits, and monitor supplier performance.

Skills

Quality engineering

FDA regulation knowledge

Statistical analysis

Lean Six Sigma

Documentation & audits

Education

Bachelor’s Degree in Chemistry or related field

Tools

Oracle

Crystal Reports

SmartCAPA

Job description

Merit Medical is seeking a Quality Engineer in Utah to perform complex quality engineering tasks across product lines under supervision. Responsibilities include risk analysis, QA documentation, ECNs, and supplier quality oversight.

Qualified candidates will have a Bachelor’s in chemistry or related field, 5 years of quality experience, and strong knowledge of 21 CFR 820 and ISO standards. This role offers multiple shifts and onsite work in Utah, with comprehensive benefits.