Rebecca MacPherson

Compliance isn't paperwork. It's a promise — to patients, to customers, to the people on your manufacturing floor. I help companies keep it.

I came into quality and compliance through an unusual door. Before I ever audited a medical device, I was a Certified Nursing Assistant at a veterans hospital, caring for people who depended on the equipment, the medications, and the systems that other people had built. I learned early that quality work isn't abstract. It's measured in patients who don't get hurt, in families who get more time, in promises that get kept.

I spent more than a decade inside Fortune 500 medical device organizations — Olympus and Terumo — climbing from the manufacturing floor to senior quality leadership. I led the team that earned EU MDR certification for my previous employer. I oversaw the Regional Complaint Investigation Center for one of the largest medical device companies in the world. I built and remediated CAPA programs, led internal and external audits, responded to warning letters, integrated 250+ new hires through a major acquisition, and trained teams across the country on the regulations that govern their work.

What I kept seeing was a disconnect: companies investing real money in quality systems that nobody on the floor actually used. Procedures so dense they were unreadable. CAPA programs that closed issues without ever solving them. Audits that found problems but somehow never fixed them. And underneath it all, smart, hardworking people who genuinely wanted to do the right thing but didn't have systems that helped them.

I founded Cornerstone Quality & Compliance Consulting LLC to bridge that gap. Smaller and mid-size companies deserve the same depth of expertise that Fortune 500 budgets buy — without the bureaucracy, bloat, or the consultant who delivers a binder and disappears.

My work is built on a few non-negotiable beliefs: quality systems should serve the people using them, not the other way around. Root causes are worth the time it takes to find them. Regulatory compliance is a floor, not a ceiling. And the measure of a good consultant isn't the engagement — it's how strong you are after they're gone.

A foundation built on Excellence.

Credentials

Rebecca holds ISO 13485:2016 and ISO 9001:2015 Lead Auditor certifications, is an ASQ Certified Quality Auditor (CQA), and holds a Six Sigma Green Belt. She earned her Bachelor of Science in Business Management from Wilmington University and has supported regulatory submissions, audits, and quality system builds across the medical device industry, with hands-on experience in FDA 21 CFR 820, EU MDR, and ISO 13485 frameworks.