01 / QUALITY SYSTEMS
QMS development & remediation
Build, repair, or strengthen the procedures and records that make quality work day to day, not just on audit day.
Discuss your system
Woodrow Starnes · Medical Device Quality Engineer
Quality systems that let your device move forward.
Woodrow Starnes helps medical device teams turn regulatory pressure into a practical plan: cleaner documentation, stronger processes, and evidence that holds up when it matters.
A focused conversation. Clear next steps. No hard sell.
Built for the realities of
Medical Devices Manufacturing Quality Engineering Growing MedTech TeamsWhere Woodrow steps in
Bring order to the work that keeps you moving.
You do not need a bigger binder. You need the right next move, backed by evidence your team can use.
02 / AUDITS & GAPS
Audit readiness & gap assessments
See what is missing before an auditor does. Get a prioritized, realistic plan to address it.
Prepare with clarity03 / VALIDATION
Validation & quality engineering
Turn complex process, equipment, and test-method requirements into defensible protocols and reports.
Plan your project04 / POST-MARKET
CAPA, complaints & nonconformance
Improve investigation quality, root-cause thinking, and closure evidence without creating busywork.
Strengthen your process05 / SUPPLIERS
Supplier quality & controls
Establish supplier evaluations, ongoing monitoring, and documentation that protect the product and the business.
Review supplier risk06 / PRACTICAL SUPPORT
Fractional quality support
Get experienced, hands-on quality support when a full-time hire is not yet the right answer.
Explore ongoing support
Founder-led support
Practical quality work, led by Woodrow Starnes.
Woodrow is a biomedical engineering professional and medical device quality engineer with experience spanning quality systems, CAPA and complaint investigations, validation, supplier controls, audits, technical documentation, and manufacturing quality.
His approach is shaped by work across medical device organizations including NovaBone Products, Zimmer Biomet, Myolyn, and Winco Manufacturing, plus a U.S. Marine Corps background that shows up in disciplined execution and direct communication.
ISO 13485:2016 Lead Auditor Training
Lean Six Sigma Green Belt
Google Project Management
Medical Device Quality Engineering
A better way to get there
Less guessing.
More forward motion.
A good quality system should make your team more capable, not slower. We start with the business reality, then build the evidence and discipline needed to support it.
01
Listen and diagnose
We start with your product, timeline, current state, and the problem creating the most risk.
02
Set the right scope
You get a clear engagement plan with priorities, deliverables, and practical milestones.
03
Build usable proof
We work beside your team to create records, systems, and decisions that stand up to scrutiny.
Who Woodrow helps
For teams with a lot at stake.
Whether you are building the foundation or cleaning up what came before, the work begins with clarity.
Early-stage MedTech
Build the quality foundation before it becomes an expensive problem.
Manufacturers
Improve validation, inspection, supplier, and production quality controls.
Quality Leaders
Bring in focused help for a project, audit, CAPA, or resource gap.
Growing Teams
Get experienced support while you build the internal capability to scale.
Start here
What is the one quality issue you cannot afford to get wrong?
Tell Woodrow where you are stuck. You will have a focused conversation about the risk, the path forward, and whether this is the right fit.
Serving medical device teams remotely and on-site as needed.