The Role
Lead investigations of non-conformances, manage containment and CAPA activities, support audits, collaborate with cross-functional teams to ensure product/process quality, analyze quality data and trends, and apply statistical and risk-management tools (e.g., FMEA) to support continuous improvement and regulatory compliance.
Summary Generated by Built In
Work Flexibility: Onsite
What You Will Do
Travel Percentage: None- Lead investigations of non-conformances and implement corrective and preventive actions to support timely issue resolution.
- Collaborate with Engineering, Production, and cross-functional teams to ensure products and processes meet quality requirements.
- Support internal and external audits by preparing documentation, participating in audit activities, and addressing audit observations.
- Escalate quality concerns to Quality Assurance and Engineering leadership and support resolution activities.
- Manage containment activities for non-conforming product, including identification, segregation, documentation, and reconciliation.
- Monitor, analyze, and trend quality data to identify risks, recurring issues, and improvement opportunities.
- Ensure compliance with the Quality Management System and applicable regulatory requirements.
- Apply statistical analysis and risk management tools, including Failure Mode and Effects Analysis (FMEA), to support decision-making and continuous improvement initiatives.
Required Qualifications
- Bachelor’s degree in Engineering or a related technical field.
- Minimum 3 years of experience in Quality Engineering.
- Working knowledge of 21 CFR Part 820, ISO 13485, and the Medical Device Single Audit Program (MDSAP).
- Advanced English proficiency, written and verbal.
Preferred Qualifications
- Experience supporting internal and external quality audits.
- Experience conducting investigations, risk assessments, and corrective and preventive action activities.
- Experience working in a regulated manufacturing environment.
- Experience using statistical analysis and quality risk management tools.
Skills Required
- Bachelor's degree in Engineering or related technical field
- Minimum 3 years of experience in Quality Engineering
- Working knowledge of 21 CFR Part 820
- Working knowledge of ISO 13485
- Working knowledge of the Medical Device Single Audit Program (MDSAP)
- Advanced English proficiency, written and verbal
- Experience supporting internal and external quality audits
- Experience conducting investigations, risk assessments, and CAPA activities
- Experience working in a regulated manufacturing environment
- Experience using statistical analysis and quality risk management tools
Inari Medical Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Inari Medical and has not been reviewed or approved by Inari Medical.
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Fair & Transparent Compensation — Pay is considered competitive for many roles, with employees described as 'extremely happy' with total compensation including pay, stock, equity, and benefits. Feedback suggests above‑average salary levels across departments contribute to strong pay sentiment.
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Healthcare Strength — Benefits include comprehensive medical, dental, and vision coverage, with 100% employer‑paid premiums for employees cited in multiple descriptions. Additional options like critical illness, accident, hospital indemnity, and wellness programs reinforce the healthcare offering.
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Leave & Time Off Breadth — Time off is characterized by unlimited PTO, cited as a top benefit by employees. Paid holidays and flexible hours are also referenced, expanding the range of time‑off options.
Inari Medical Insights
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The Company
What We Do
Inari Medical, Inc. is a commercial-stage medical device company focused on developing products to treat and transform the lives of patients suffering from venous diseases.
