Job Title:  Senior Quality Supervisor

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 13485:2016, 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)