The Senior Quality Supervisor provides both strategic and operational leadership for the Quality function at the Reynosa site, ensuring regulatory compliance, process efficiency, and continuous improvement of quality performance. This role is responsible for executing the quality strategy, managing risk, driving data-based decision-making, and influencing cross-functional teams including Operations, Engineering, R&D;, and Supply Chain. The position acts as a technical expert and organizational leader to ensure operational excellence and customer satisfaction.
Key Responsibilities:
Lead the execution of the quality strategy aligned with business objectives
Oversee and continuously improve the Quality Management System (QMS)
Monitor and drive improvement of Quality KPIs
Act as key point of contact for internal, customer, and regulatory audits
Lead complex problem-solving initiatives ensuring sustainable solutions
Develop, mentor, and lead the Quality team
Collaborate cross-functionally to ensure quality is built into design and manufacturing
Lead CAPA processes ensuring effectiveness and compliance
Oversee document control, DMRs, and change management within the QMS
Drive cost reduction initiatives related to quality (scrap,



rework, complaints)
Ensure robust supplier quality management and incoming inspection processes
Analyze quality trends and implement preventive actions
Improve inspection, testing, and validation processes
Oversee calibration programs and ensure metrology compliance
Requirements:
Bachelor's degree in Engineering or related field (required)
5–8 years of progressive experience in Quality
Minimum 2–3 years leading teams
Experience in medical device or highly regulated industry (preferred)
Proven experience leading audits (FDA, ISO, MDSAP)
Experience driving continuous improvement or Lean Six Sigma initiatives
Advanced English proficiency
Strong knowledge of ISO *****:****, MDSAP, EU MDR
Knowledge of FDA 21 CFR Part 820 and cGMP requirements
Expertise in CAPA, NCR, and audit processes
Strong problem-solving skills (8D, 5 Whys, Fishbone)
Knowledge of SPC and statistical analysis tools
Advanced understanding of manufacturing processes
Ability to read and interpret engineering drawings and specifications
Six Sigma Green Belt or Black Belt (preferred)

📌 Senior Quality Supervisor (México)
🏢 Ametek
📍 México