Carlos C Cruz (3C)

Fixing Quality Systems. Enabling FDA Readiness. Accelerating Product Execution.

25+ years in medical devices industry from industry leaders as well as growth stage teams; leading quality, manufacturing, and regulatory efforts to resolve CAPAs, stabilize QMS, and move products forward under pressure.

Let’s connect if you’re dealing with CAPA, audit, or scale-up challenges.

Where I Get Called In

• CAPAs that stall, reopen, or fail during audits

• FDA or ISO 13485 findings that require fast, credible resolution

• QMS gaps impacting product release or scale-up

• Validation issues (IQ/OQ/PQ, design validation)

• Manufacturing transfers where quality breaks down

• Cross-functional misalignment slowing execution

About

I’ve spent over 25 years in the medical device industry working across engineering, manufacturing, and quality—ultimately leading QA/RA functions in regulated environments.

My focus has been consistent: align systems, remove execution gaps, and ensure products move forward without regulatory or operational breakdown.

I operate comfortably in high-pressure situations where teams need both strategic direction and hands-on execution.

Selected Impact

• Supported FDA and ISO 13485 environments across multiple product lines

• Led validation and process alignment for manufacturing transfers

• Helped teams close audit gaps and stabilize QMS under pressure

• Bridged engineering, quality, and operations to accelerate product readiness

• Strengthened CAPA systems to improve effectiveness and audit outcomes

How I Engage

• Leadership roles (Quality / Regulatory / Engineering)

• Advisory and project-based engagements

• Interim or transitional leadership

I operate hands-on where needed, but always with a focus on building sustainable systems—not temporary fixes.

Let’s Connect

If you’re dealing with audit pressure, CAPA challenges, or scaling issues, I’m open to connecting.

Open to leadership roles or select engagements where I can help resolve complex quality, regulatory, or operational challenges.

Contact

You can email me at: Carlos@CarlosCCruz.com with your:

Name
Company
Role
Brief description of the situation