Summary

Responsible for HT quality plan, culture initiatives and monitoring of objectives and KPIs. Own the integral QMS training strategy; develop minimal requirements for training, onboarding and refresher training for all HT employees, assign, and track mandatory compliance training to ensure organization-wide competency. Improve and harmonize QMS policies across global sites to ensure consistency in compliance. Oversee the lifecycle of controlled documentation and data integrity. Manage the Corrective and Preventive Action (CAPA) system to ensure systemic issues are identified and closed. Global assessments across sites and management of CAPAs.

Responsibilities

- Develop and provide training for all HT employees ensuring training and awareness compliance across the HT organization.
- Ensure full execution of the quality plan and objectives.
- Lead the HT CAPA process and indicators ensuring compliance across HT facilities.
- Lead internal audit programs and serve as lead for external regulatory inspections (FDA, Notified Bodies), managing the inspection readiness program.
- Improve HT quality agreement templates and processes; support site quality leaders in negotiations and approval of quality agreements; lead internal supplier agreements across sites.

Travel Requirements

Travel to foreign countries is required; travel requirements greater than 50%. A passport is necessary.

Qualifications

- Education: Bachelor’s degree in Engineering, Life Sciences, Quality Management, or a related technical discipline. An advanced degree (Master’s or MBA) is preferred.
- Experience: Minimum of 7-10 years in quality assurance/QMS role within the medical device industry, with at least 3 years in a global or multi‑site managerial capacity.
- Required experience in quality system (ISO 13485) applications of medical device manufacturing and/or design; direct participation in FDA inspections.




- Understanding of medical device statutes, standards and regulations to discuss, apply and resolve complex compliance issues with highly educated and professional teams.
- Proven track record of successfully leading major regulatory audits (FDA, Notified Bodies) and managing comprehensive QMS integrations.

Skills & Competencies

- Expert knowledge of ISO 13485, FDA 21 CFR Part 820, Device Regulations (EU MDR) is a plus.
- Strong leadership and cross‑functional collaboration skills, with the ability to influence global teams.
- Excellent analytical and risk management capabilities (ISO 14971 familiarity is a plus).
- Ability to translate complex regulatory and procedural information into clear, accurate, and accessible documentation.
- Proficiency in developing detailed protocols, such as CAPA reports, non‑conformance records, and validation documentation, where technical accuracy is critical to patient safety and product quality.
- Excellent communication skills, both written and verbal, for presenting compliance strategies to senior management.

Physical Demands

Regularly sitting/standing, free to move around. Occasionally sustained visual concentration on small areas, such as monitors and screens. Regularly sustained visual concentration on numbers, legal documents.

EEO Statement

Celestica is an equal opportunity employer. All qualified applicants will receive consideration for employment and will not be discriminated against on any protected status (including race, religion, national origin, gender, sexual orientation, age, marital status, veteran or disability status, or other characteristics protected by law). At Celestica we are committed to fostering an inclusive, accessible environment, where all employees and customers feel valued, respected and supported. Special arrangements can be made for candidates who need it throughout the hiring process. Please indicate your needs and we will work with you to meet them.

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📌 10 - Manager, Global QMS (Monterrey)
🏢 Celestica
📍 Monterrey