Associate Quality Engineer
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. 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 with regulatory requirements (ISO 13485:2016, MDSAP, EU MDR 2017/745) and that products meet all applicable internal and external requirements and specifications.
Requirements
- Adaptable to a fast-paced environment
- Attention to detail and focus on the identification of potential issues and continuous improvement
- Basic computer skills (Excel, Word, Dropbox, etc.)
- General knowledge of: ISO 13485:2016
- General knowledge of: 21 CFR 820 Quality System Regulation
- 1+ years of experience in a quality role in a 13485 or FDA Regulation environment.
- Experience with sampling plans and other statistical methodologies
Responsibilities
- Collaborate with cross-functional teams to address quality issues and drive improvements.
- Investigate and resolve quality issues
- Assist in performing Cause Analysis and implement corrective & preventive actions.
- Assist in developing and executing quality assurance test protocols.
- Participate in strategic quality initiatives and projects.
- Participate in risk management activities.
- Follow guidance on regulatory compliance and quality standards.
- Supporter in internal, supplier, and external audits.
- Excellent communication and teamwork abilities.
- Familiarity of regulatory requirements and quality management systems.
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
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
Associate degree
