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, UT facility.
RESPONSIBILITIES: - Collaborate with cross-functional teams to address quality issues, drive improvements, and provide guidance for design transfer activities.
- Perform Root Cause Analysis and implement corrective & preventive actions.
- Oversee development and execution of quality assurance test protocols.
- Identify and plan strategic quality initiatives and projects.
- Oversee risk management activities.
- Provide expert guidance on regulatory compliance and quality standards.
- Key leader for internal, supplier, and external audits.
- Strong leadership with the ability to direct the quality team while providing feedback and mentorship.
- 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
- Ability to develop KPIs and key site objectives for Quality.
- Attention to detail and focus on the identification of potential issues and continuous improvement
- Experience with eQMS systems, Dropbox, Microsoft (PowerPoint/Word/Excel), and metrology SW.
REQUIRED EDUCATION & EXPERIENCE: - An Engineering degree or other relevant field, plus years of relevant experience (Medical Device) as defined below:
- Associate's degree + 8 yrs of medical device experience
- Bachelor's degree + 7 yrs of medical device experience
- Master's degree + 5 yrs of medical device experience
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.
