Staff Internal Quality Auditor

Posted Yesterday
Be an Early Applicant
6 Locations
In-Office or Remote
Junior
Healthtech
The Role
Lead internal QMS audits from planning through execution, reporting, and follow-up. Assess compliance to FDA, ISO 13485, MDR/MDD and company procedures; document nonconformances; present findings to site leadership; support the global audit program; monitor observations and escalate systemic risks while interfacing with RAQA and quality leaders.
Summary Generated by Built In
Work Flexibility: Remote

What you will do:

Responsible for independently leading internal audits to assess compliance and effectiveness of the Quality Management System (QMS). Partners with site stakeholders to drive compliance, identify risks, and support continuous improvement.

  • Lead internal audits from planning through execution, reporting, and follow-up

  • Develop and tailor audit scope, agenda, and plans based on site inputs

  • Assess compliance to FDA, ISO 13485, MDR/MDD, and company procedures

  • Document audit results, including nonconformances and observations

  • Present audit results and insights to site leadership

  • Support execution of the Global Internal Audit Program

  • Monitor audit observations and escalate trends or systemic risks

  • Interface with Site RAQA and Quality leadership teams

What you need:

Required:

  • Bachelor’s degree in engineering, science, business administration or related field.

  • Certified Lead Auditor (or equivalent quality auditing certification) required

  • At least 2 years of experience auditing in a regulated industry

  • Fluent in both English and Spanish required

  • Working knowledge of FDA and ISO 13485 requirements

Preferred:

  • Auditing experience in medical device or pharmaceutical industries

Travel Percentage: 40%

Skills Required

  • Bachelor's degree in engineering, science, business administration or related field
  • Certified Lead Auditor or equivalent quality auditing certification
  • At least 2 years of experience auditing in a regulated industry
  • Fluent in both English and Spanish
  • Working knowledge of FDA and ISO 13485 requirements
  • Auditing experience in medical device or pharmaceutical industries

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.

  • 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.
  • 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.
  • 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

Am I A Good Fit?
beta
Get Personalized Job Insights.
Our AI-powered fit analysis compares your resume with a job listing so you know if your skills & experience align.

The Company
HQ: Irvine, CA
956 Employees

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.

Similar Jobs

Stryker Logo Stryker

Staff Internal Quality Auditor

Healthtech • Other • Robotics • Biotech • Manufacturing
In-Office or Remote
6 Locations
51000 Employees

PwC Logo PwC

Business Integrity Trade Compliance Senior Manager

Artificial Intelligence • Professional Services • Business Intelligence • Consulting • Cybersecurity • Generative AI
Remote or Hybrid
68 Locations
370000 Employees
91K-322K Annually

PwC Logo PwC

IT Infrastructure Managed Services - Sales Director

Artificial Intelligence • Professional Services • Business Intelligence • Consulting • Cybersecurity • Generative AI
Remote or Hybrid
59 Locations
370000 Employees
155K-410K Annually

PwC Logo PwC

Consultant

Artificial Intelligence • Professional Services • Business Intelligence • Consulting • Cybersecurity • Generative AI
Remote or Hybrid
66 Locations
370000 Employees
99K-232K Annually

Similar Companies Hiring

Sailor Health Thumbnail
Healthtech • Social Impact • Telehealth
New York City, NY
20 Employees
Granted Thumbnail
Mobile • Insurance • Healthtech • Financial Services • Artificial Intelligence
New York, New York
23 Employees
OneImaging Thumbnail
Healthtech
Miami, FL
62 Employees

Sign up now Access later

Create Free Account

Please log in or sign up to report this job.

Create Free Account