Quality Engineer II: Medical Device QA & Compliance

Laborie Medical Technologies Corp; Murray (UT); On-site; USD 85,000 - 110,000; Full time

Benefits offered by this job

PTO

Medical insurance

Dental and Vision

HSA contributions

401k with company match

Parental Leave

Wellness programs

Job summary

Laborie Medical Technologies Corp in Murray, UT, is seeking a Quality Engineer II to ensure product and process conformity to requirements and to maintain QMS documentation. The role supports operations, contract manufacturers, and R&D while coordinating audits, CAPA, and risk assessments.

Minimum qualifications include 5+ years in medical device quality engineering, a BS in engineering or science, and knowledge of FDA QSR and ISO 13485.

Qualifications

• 5+ years medical device quality engineering experience.
• BS in engineering or science.
• Strong knowledge of FDA QSR and ISO 13485 requirements.
• Critical thinking and sound decision-making skills.
• Excellent written and verbal communication skills.
• Ability to independently solve problems, lead projects and influence teams.
• Demonstrated ability to work as a team player with multi-disciplinary project teams.
• Demonstrated ability to interpret technical information.
• Experience with quality audits (lead auditor certification preferred).
• ASQ certification preferred.
• Lean Six Sigma training preferred.

Responsibilities

• Establish and maintain documentation for inspection and release of materials and finished devices.
• Perform quality activities in support of Operations, contract manufacturers and R&D.
• Schedule and document calibration and maintenance activities.
• Support design and engineering change processes and associated documentation.
• Support internal and external audit activities and resolve nonconformities.
• Perform and support process and equipment validations.
• Investigate, disposition and close nonconformities.
• Investigate and close product complaints.
• Collect and evaluate quality data for process monitoring and post-market surveillance.
• Perform quality activities related to CAPA processes.
• Represent Quality Engineering in risk assessments (pFMEA, DFMEA).
• Participate in Material Review Board reviews including material segregation and dispositions.

Skills

Quality engineering

Auditing

Cross-functional collaboration

Communication skills

Problem solving

Project leadership

Education

BS in Engineering or Science

Tools

CAPA systems

FMEA / PFMEA

Root cause analysis

Documentation control

Job description

Laborie Medical Technologies Corp in Murray, UT, is seeking a Quality Engineer II to ensure product and process conformity to requirements and to maintain QMS documentation. The role supports operations, contract manufacturers, and R&D while coordinating audits, CAPA, and risk assessments.

Minimum qualifications include 5+ years in medical device quality engineering, a BS in engineering or science, and knowledge of FDA QSR and ISO 13485.