Quality Assurance Specialist

About Route 92 Medical

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/

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:

This position will support Route 92 Medical's efforts to sustain a best practice Quality System by ensuring compliance to regulatory requirements (13485:2016, MDSAP, EU MDR 2017/745) as well as ensuring products meet all applicable internal and external requirements and specifications. This is an onsite role in our West Jordan, Utah facility - on a hybrid work schedule once proficiency is reached.

RESPONSIBILITIES:

• Collaborate with cross-functional teams to address quality issues, drive improvements, and provide guidance.
• Coordinate, plan, and perform internal audits and audit corrective actions.
• Coordinate and verify corrective & preventive actions (CAPA).
• Coordinate and verify nonconforming material activities (MRB) and Quality Events (QE).
• Training coordinator responsibilities include generating, maintaining, and executing as required.
• Support Document Control as needed.
• Support Supplier Management activities
• Support intake of complaints
• Generate and/or update QMS documentation, such as:
• Standard Operating Procedures
• Work Instructions
• Product documentation
• Support maintenance of Technical Documentation and Design History Files.
• Supports implementation of opportunities for improvement.
• Other Quality System activities as required.
• Excellent communication and cross-functional teamwork abilities.
• Knowledge and Experience of regulatory requirements and quality management systems.

SKILLS FOR SUCCESS:

• Adaptable to a fast-paced environment
• Professional expertise, ability to apply company policies and procedures to resolve issues.
• Attention to detail and focus on the identification of potential issues and continuous improvement
• Experience with Salesforce based eQMS systems, Dropbox, Adobe, and Microsoft (PowerPoint/Word/Excel).

REQUIRED EDUCATION & EXPERIENCE:

• A degree or other relevant field plus years of relevant (medical device) experience as defined below:
• Associates degree + 4 yrs of medical device experience
• Bachelor's degree + 2 yrs of medical device experience
• Master's degree

BENEFITS & PERKS

• Comprehensive healthcare benefits are effective day one! R92M offers generous benefit options, including but not limited to: Medical, Dental, Vision, Life Insurance, FSA, HSA, Short- & Long-Term Disability, Critical Illness Insurance, and Accident Insurance.
• Competitive base pay plus corporate bonus program
• Generous vacation policy, 16 paid holidays, and 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

The actual base pay is dependent upon many factors, such as: work experience, market data, skills, geographic location, and business need. The base pay range is subject to change and may be modified in the future. This role may also be eligibility for equity.