Quality Engineer II

Laborie; Salt Lake City (UT); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Paid time off

Medical, Dental, Vision insurance

Health Savings Account

401k with company match

Parental Leave

Job summary

Laborie is seeking a Quality Engineer II to ensure product and process conformity with FDA QSR and ISO 13485. You will build and maintain documentation, support audits, and collaborate with operations, R&D, and suppliers to drive quality across medical devices.

Join a team that values collaboration, accountability, and continuous improvement. You will lead investigations, CAPAs, and risk assessments, and contribute to design and process changes that enhance patient safety.

Qualifications

• 5+ years in medical device quality engineering.
• B.S. 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 raw materials, sub-assemblies and finished medical 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 work to resolve audit nonconformities.
• Perform and support process, equipment validations.
• Investigate, disposition and close nonconformities.
• Investigate and close product complaints.
• Collect and evaluate quality data for process monitoring, management review and post market surveillance.
• Perform quality activities related to CAPA processes.
• Represent Quality Engineering in the development and maintenance of process and product risk assessments (e.g. PFMEAs DFMEA).
• Participate in Material Review Board reviews including material segregation, investigation, corrections and dispositions

Skills

Quality engineering

FDA QSR

ISO 13485

ASQ certification

Lean Six Sigma

Education

B.S. in engineering or science

Job description

We believe that great healthcare is an essential safeguard of human dignity. At Laborie, we know the work we do matters – it’s what fuels our motivation and contributes to our success. If you’re ready to make a positive impact in the lives of patients across the globe, we’d like to meet you. We support and empower our employees to grow their careers in an environment that encourages a sense of belonging and a connection to doing good. We’re not afraid to roll up our sleeves to make our goals a reality and work together to solve for our customers. We we reward and recognize our employees based on our values of Aspire to Greatness, Respect All, Own It, Working Together, Persist with Passion.

Who We’re Looking For:

The Quality Engineer II ensures product and process conformity to requirements. Ensuring documentation in conformance to the Quality Management Systems and applicable standards and regulations.

About the Role

• Establish andmaintaindocumentation for the inspection and release of raw materials, sub-assemblies and finished medical devices
• Perform quality activities in support of Operations, contractmanufacturersand 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 work to resolve audit nonconformities.
• Perform and support process, equipment validations.
• Investigate,dispositionand close nonconformities.
• Investigate and close product complaints.
• Collect and evaluate quality data for process monitoring, managementreviewand post market surveillance
• Perform quality activities related to CAPA processes
• Represent Quality Engineering in the development and maintenance of process and product risk assessments (e.g.pFMEAsdFMEA)
• Participate in Material Review Board reviews including material segregation, investigation,correctionsand dispositions

Minimum Qualifications

• At least 5 years Medical Device quality engineering experience
• B.S. 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, leadprojectsand 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

Why Laborie

Our Mission every day is to operate as a world-class specialist medical company making and advancing technologies that preserve and restore human dignity. We do that today by helping people with pelvic and gastrointestinal conditions live normal lives, and by helping mothers and babies have safe deliveries.

• Paid time off and paid volunteer time
• Medical, Dental, Vision and Flexible Spending Account
• Health Savings Account with Company Funded Contributions
• 401k Retirement Plan with Company Match
• Parental Leave and Adoption Services
• Health and Wellness Programs and Events

Laborie providesequal employment opportunities and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Laborie is committed to providing access and reasonable accommodation in our services, activities, education, and employment for individuals with disabilities.