- QMS for Class II/III medical device manufacturing

- Design Transfer, Validation, Supplier Quality, and FDA/ISO compliance.

About Our Client

International Medical Devices Manufacturer

- Lead the site Quality organization and serve as the primary representative for quality and regulatory matters.

- Ensure compliance with FDA, cGMP, ISO, and other applicable integral regulations.

- Oversee and continuously improve the Quality Management System (QMS).

- Drive quality strategy, operational excellence, and harmonization of quality processes across the organization.

- Lead investigations, CAPA activities, quality metrics reviews, and risk mitigation initiatives.

- Assess Quality team capabilities, identify organizational gaps, and implement development plans.

- Champion the transition from manual processes to digital and AI-enabled quality solutions.

- Promote a mindset of accountability, collaboration, and continuous improvement.

- Partner with Manufacturing, Engineering, Supply Chain, and other stakeholders to improve business performance.

- Drive budget adherence, cost-control initiatives, and sustainable quality improvements.

The Successful Applicant





- Bachelor's degree in Engineering, Science, or related technical field; advanced degree preferred.

- 10+ years of Quality experience within Medical Devices and/or Pharmaceutical manufacturing.

- 5+ years leading managers and multidisciplinary Quality teams.

- Strong expertise in Class II/III medical device manufacturing processes, Design Transfer, Manufacturing Specifications, Supplier Qualification, Validation Strategy, and Production & Process Controls.

- Extensive knowledge of FDA 21 CFR, cGMP, ISO 13485, and regulated manufacturing environments.

- Demonstrated success leading organizational change and improving team performance.

- Strong analytical, problem-solving, and root cause investigation skills.

- Excellent communication, stakeholder management, and executive influencing capabilities.

- Experience identifying quality gaps, solving market-impacting quality issues, and driving measurable operational improvements.

What's On Offer

Competitive Compensation Package

Contact: Stefano Frausto

Quote job ref: JN-072026-7057292

📌 Quality Sr. Manager - Medical Devices (Jalisco)
🏢 Michael Page
📍 Jalisco