Quality Engineer

Route 92 Medical Inc • West Jordan, UT

40d

About The Position

Route 92 Medical is on a mission to improve outcomes for patients undergoing neurovascular intervention. At the core is a reconsidered procedural approach, cutting-edge engineering, and innovative product design. Our portfolio targets the most significant challenges in neurointerventional care to deliver meaningful solutions. The company was founded by physicians developing thoughtful product solutions in collaboration with the world’s leading clinicians, who focus on improving procedural and patient outcomes.

https://www.route92medical.com/ [https://www.route92medical.com/]

Chart a new course

Route 92 Medical is looking for dynamic, innovative people who are inspired by our mission to improve outcomes for patients undergoing neurovascular intervention.

We welcome team members who approach their work with courage, flexibility, persistence, and a willingness to assist others. Teamwork matters here. We are committed to collaboration and finding innovative solutions that advance neurovascular intervention, establishing Route 92 Medical as one of the premier companies in the field.

PURPOSE OF JOB:

Support Route 92 Medical’s efforts to sustain a best practice Quality System by ensuring compliance to regulatory requirements such as FDA QSR, ISO 13485 and EU MDR, and that products meet all applicable internal and external requirements, from new product conception, development, through product launch.

Requirements

• General knowledge of: EU MDR 2017/745
• ISO 13485:2016
• 21 CFR 820 Quality System Regulation
• ISO 14971:2019 Risk Management
• Associated Degree with CQE or a Bachelor’s Degree is required
• 2+ years of experience in a quality role in a 13485 or FDA Regulation environment.
• Experience with sampling plans and other statistical methodologies

Responsibilities

• Identify, investigate and disposition nonconforming material
• Perform Cause Analysis and implement corrective & preventive actions.
• Support development and execution of inspections and test methods
• Develop and support equipment qualification and maintenance activities
• Assist in developing and executing quality assurance test protocols.
• Support internal, supplier, and external audits.
• Support strategic quality initiatives and projects
• Follow guidance on regulatory compliance and quality standards
• Collaborate with cross-functional teams to address quality issues and drive improvements.
• Identify and implement Quality Management System improvements.

Benefits

• Comprehensive healthcare benefits are effective day one! R92M offers generous benefit options, including Medical, Dental, Vision, Life Insurance, FSA, HSA, Short-term and Long-term disability, Critical Illness Insurance, and Accident Insurance.
• Competitive base pay plus corporate bonus program
• Generous paid time off and 16 paid holidays, including a company-wide summer recharge week in July
• 12 weeks of paid parental leave for employees after 90 days of employment
• Monthly cell phone stipend

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Associate degree