Internal Quality Auditor

Make Your Mark on a Growing Audit Team

We're looking for a highly motivated quality expert to join a growing device startup in the pain management/neuroscience space with two products in late-stage development and one product on the market. The ideal candidate will have experience with combination products in an ISO13485 environment, and at least two years of experience with internal quality audits. Your main responsibility will be to improve and implement audit programs, policies, and practices that lead to safer, more effective products that reduce risk for both the consumer and the company.

If you've been looking to take the next step in your career and impact an Audit program, this is the role for you.

Responsibilities:

Process owner and subject matter expert for the Quality Management System Audit Processes

Conducts internal quality system audits and supplier quality audits

Creates and maintains internal/supplier audits schedule and associated metrics

Manages internal audit program

Supports CAPA and SCAR investigations

Communicates and coordinates audit activities with other departments

Completes required documentation, files, reports, and records in a timely manner

Plans, organizes, and provides training related to Quality Management System auditing and regulatory compliance, as necessary

Assists in the revision, writing, and/or review of SOPs and work instructions to identify areas of compliance and process improvements

Performs other related duties and responsibilities, as assigned

Qualifications:

4+ years of medical device (class II and III) industry experience

2+ years' experience in quality system compliance audits

ASQ certification for Quality Management or Auditing

1+ year of internal audit experience

GxP experience required

Ability to solve problems, apply critical thinking skills, and an aptitude for seeing the big picture

Excellent written and verbal communication skills

Bonus Points for:

Experience with combination products

Technical writing/investigation experience

Why Choose Us?

This rapidly growing organization is pioneering new products and offers incredible long-term career opportunities. Recent funding paves the way for more innovation and an expansion into the market.

Apply now and come work with world-class innovators.

IND123