Open to opportunities

Audrey Sheppard

@audreysheppard

Message

I build compliant quality systems and validation records for medical devices.

United States

Message

What I'm looking for

I'm looking to continue supporting medical device quality, design controls, validation, risk management, and post-market lifecycle activities in a regulated environment where I can strengthen compliant documentation and manufacturing readiness.

At LivaNova, I support the lifecycle of implantable medical devices through complaint investigations, risk analysis, design and process changes, validation review, and controlled documentation.

I lead and review IQ/OQ/PQ validation protocols and reports, maintain post-market risk assessments and FMEAs, and support FDA PMA and EU MDR submissions. I also help prepare teams for ISO 13485 audits and FDA inspections.

Previously, at CardioQuip, I restructured a post-market device Design History File for FDA requirements, created verification, validation, and process-validation protocols, and authored manufacturing instructions for devices and wiring harnesses.

My biomedical engineering background includes regulated manufacturing of more than 1,000 absorbable IVC filters at Adient Medical. I'm an ASQ Certified Quality Engineer and Lean Six Sigma Green Belt who translates engineering requirements into clear, manufacturing-ready controlled records.

Experience

Work history, roles, and key accomplishments

Current

Quality Engineer II

Current

LivaNova

Feb 2024 - Present (2 years 7 months)

Provide lifecycle engineering and quality support for implantable medical devices, including complaint investigations, risk analysis, design/process changes, and validation review. Lead IQ/OQ/PQ process validation and maintain risk management files per ISO 14971.

Medical Device Design Design Files Design And Validation Test Protocols Process Validation ISO 13485 ISO 14971 Complaint Investigation Failure Analysis Risk Management Change Control Deviations Regulatory Submissions Cross functional Coordination Microsoft Office

Biomedical Engineer I

Adient Medical Inc.

Jan 2023 - Feb 2024 (1 year 1 month)

Executed and documented regulated manufacturing processes for absorbable inferior vena cava filters, ensuring compliance with approved procedures and quality requirements. Collaborated with engineering and production teams to address process issues and support change implementation.

Manufacturing Process Compliance Documentation Process Improvement Collaboration

Project Engineer I

CardioQuip, LLC

May 2022 - Jan 2023 (8 months)

Revised and implemented design and development procedures for medical devices, supporting QMS maintenance and compliant design-control practices. Conducted design reviews and restructured Design History Files to improve traceability and audit readiness.

Design Control Design Files QMS Design Verification Process Validation

Production Personnel

Adient Medical Inc.

Jun 2016 - Jan 2023 (6 years 7 months)

Executed and documented regulated manufacturing processes for medical devices, maintaining adherence to approved procedures and quality requirements.

Manufacturing Documentation

Quality Engineering Intern II

CardioQuip, LLC

May 2021 - May 2022 (1 year)

Supported design and development procedures for medical devices, including design reviews and quality documentation. Created and performed design verification and process validation protocols.

Design Verification Process Validation Quality Documentation