Principal Quality Engineer (Risk Management)

This individual will own end to end risk management process defined as (The systematic application of management policies, procedures and practices to the tasks of analyzing, evaluating, controlling and monitoring risk.)

This engineer will own the risk management process and lead in the development, maintenance and continuous improvement of the global medical device risk management files, strategies, and procedures for INARI medical products and processes. This individual will work
closely with Quality Engineering, R&D, Manufacturing Engineering, and post-market Quality Teams to achieve a world-class risk management process and execution including post- market Health Hazard Evaluations. This individual will play a key role in achieving products of the highest quality and maintain regulatory compliance to medical device risk management standards and regulations, including ISO 14971 and the EU MDR requirements.

Responsibilities

•  Administer and continuously improve the INARI Medical Risk Management Program.
• Own the KPIs related to accuracy, timeliness, and effectiveness of the various risk
  documents such as Health Hazard Evaluations, Field Risk Assessments and Risk
  Analysis related to product, process, and document changes.
• Develop, establish, and maintain product risk management files with various inputs (Post
  Market Surveillance, Product changes, Manufacturing Updates, Labeling changes etc.).
• Lead activities to maintain a closed-loop Risk Management process that incorporates information obtained from post-market surveillance into new product development, process improvements, and clinical evaluation reports.
• Work closely with Medical Affairs to establish an appropriate and consistent hazards/harms list.
• Ensure adequate stakeholder engagement, awareness, training, and support across Quality, Regulatory, Medical Affairs, Clinical Operations, Customer Care R&D and beyond to ensure robust implementation and management of the program.
• Support Post-market Quality activities with review of reportability decisions related to
  adverse events.
• Lead the risk management function while facilitating Risk Management activities within
  product development (Design and Use), manufacturing processes (PFMEAs), and the post-market surveillance phase.
• Assist post-market quality team with optimizing product investigation process.
• Present the status of the Risk Management process and activities to executive management at Quality Management Reviews and external audits, including FDA and Notified Body audits.
• Perform other duties and projects as assigned.

Qualifications

• Bachelor’s degree in engineering, Technical or Medical/Clinical field.
• Minimum 8 years’ relevant experience required.
• Experience in design quality engineering or post market quality for medical devices.
• Excellent verbal and written communication skills.
• Effective ability to communicate and build rapport with cross-functional partners including Medical Affairs.
• Detail oriented; deliver high quality product consistently and on time.
• Thrive in a fast-paced and dynamic work environment.
• Computer skills including statistical/data analysis and report writing skills.
• Thorough knowledge of medical device regulatory requirements and standards.
• Highly experienced in medical device Risk Management.

Inari Medical offers competitive health and wealth benefits for our employees. The base pay range for this position is $115,000 - $135,000. A range of factors, including location, skills, and experience, will be considered. Actual compensation may vary.