Senior Quality Engineer

A LITTLE ABOUT US: Laborie Medical has an immediate opening for a Sr Quality Engineer at our fastest growing facility.  The facility located in Salt Lake City, UT responsible for development and manufacturing of our drug-coated balloon technology used in interventional urology to treat men suffering from urinary tract conditions like urethral strictures and benign prostatic hyperplasia.

WE ARE SEEKING: Sr. Quality Engineer to support our Class III products at our state-of-the-art facility located in Salt Lake City reporting to the Sr Director of Quality. This is a hands-on, highly visible position at our fastest growing facility.

WHAT YOU GET TO DO:

• Plan and conduct activities involving the quality assurance of processes, materials, and products and assisting in the management of Quality Systems, Quality Assurance and Quality Control
• Lead, plan, coordinate and investigate CAPAs
• Lead Material Review Board and investigate product and process nonconformances
• Lead the investigation of product complaints
• Lead, plan and resolve audit nonconformities
• Provide quality leadership and direction to colleagues to drive a quality-focused mindset
• Drive supplier excellence at service providers and raw material suppliers
• Perform reviews and approvals on document change orders, protocols, reports, investigations, procedures and work instructions
• Proactively identify and resolve internal and external compliance risks
• Assist with hosting external regulatory audits

WHAT ABOUT YOU? Apply if you have...

• At least 2 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, lead projects and influence teams
• Demonstrated ability to work as a team player with multi-disciplinary project teams
• Demonstrated ability to interpret technical information

IT’D BE TERRIFIC IF YOU ALSO HAD:

• ASQ Certifications
• Drug-device combination product experience
• Class III device experience

Why Join us? We have a start-up culture, fast-paced growth and great people. We’re investing in our business and we need talented people to help us achieve our growth goals.

If you are looking to make an impact in a growing organization, this is THE opportunity for you

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 provides equal 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.