Quality Auditor
On-siteMorrisville, North Carolina, United States
Job Summary
Plan, execute, and document internal quality system audits while tracking observations and following up on resolutions. Compile and report audit metrics, provide interpretation and consultation to project teams on regulations, and assist in developing the corporate auditor training program. Train and mentor site quality auditors and new hires, presenting educational content to other functions as needed. Adhere to company policies and ensure compliance with FDA Title 21 CFR 820 QMSR and ISO 13485:2016 standards. This role supports the Strategic Compliance department within Global Operations, focusing on improving quality and service for customers across anesthesia, emergency medicine, and other therapy areas.
Required Qualifications
- Up to 50% travel
- Bachelor's degree in technical field
- Minimum of 5 years of experience in a quality or regulatory role in the pharmaceutical or medical device industries
- Minimum of 2 years of experience performing internal or supplier audits as the lead auditor
- Fluency in English
- Understanding and application of quality systems
- In depth understanding and interpretation experience for FDA Title 21 CFR 820 QMSR
- In depth understanding and interpretation experience for ISO 13485:2016
- Strong communication and interpersonal skills with a broad spectrum of people from varying backgrounds, education and experience
- Ability to understand technical operations, processes and validation
- Critical thinking, logic and analytical skills
- Documentation, organization and time management skills
- Technical writing skills
- Ability to operate with limited supervision within defined parameters
- Commitment to Goals
- Continuous Improvement
- Culture and Values
- Patient Focused
- Accountable
- Preventive
- Solution Minded
Desired Qualifications
- Fluency in Spanish, German and/or Czech
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