Operations Director (Santiago de Querétaro)

MAIN PURPOSE OF ROLE: Provide strategic and operational leadership for a multi‑product, FDA‑regulated manufacturing organization. This role shapes production strategy, ensures compliant and efficient operations across multiple shifts, and builds scalable manufacturing capabilities aligned to business objectives. Partnering cross‑functionally with R&D, Quality, Regulatory, Supply Chain, and Engineering, the role enables successful product transitions, drives continuous improvement, mitigates operational risk, and develops high‑performing teams to deliver quality, cost, and supply excellence.

Responsibilities

• Highly experienced in Production management.
• In addition to the day‑to‑day managerial function, incorporate the strategic and policy development aspects that have medium‑term consequences on the operation of the function and may impact organizational performance.
• Key member in the formulation of production strategy, policy and procedures.
• Develop and oversee production activities to maximize resource use and meet established production specifications and schedules.
• Oversee manufacturing activities of multiple product lines operating on multiple shifts.
• Develop and implement short and long‑term strategic plans to ensure manufacturing systems meet business objectives.
• Work cross‑functionally with R&D, Quality, Clinical, Regulatory and other departments to ensure effective product transitions into production.
• Work with Supply Chain management to develop effective production planning and inventory systems; ensure accurate tracking and accounting of materials and WIP.
• Work with Continuous Improvement and Engineering functions to develop effective manufacturing processes capable of meeting quality, cost and supply chain objectives.
• Anticipate and resolve high‑level issues and conflicts that could impact operational success.
• Hire and retain a diverse, highly qualified staff; provide ongoing performance feedback. Set goals aligned to department plans and manage execution through coaching and mentoring. Maintain a safe and professional work environment.
• Support all company initiatives identified by management and in support of QMS, EMS, and other regulatory requirements.
• Comply with U.S. Food and Drug Administration regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments. Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

Qualifications

Master’s degree in Industrial Engineering, Business Administration, or Engineering fields. Experience & Background: (+5 years). Fully bilingual (English & Spanish). Ability to travel approximately 25‑50%, including internationally.

Manufacturing and Operations

• Experience leading manual operations at a large scale.
• Knowledge of Med Device products is preferred; knowledge of FDA regulations and highly regulated environment is a plus.

Validations and Ramp‑up Production

• Experience in line transfers for highly regulated environments.
• Experience training large organizations and achieving ramp‑ups.
• Experience conducting self‑inspections in a GMP context based on FDA requirements, COFEPRIS, EMA requirements.

Financial Acumen

• Knowledge of financial statements; experience in planning, budgeting, forecasting.
• Manage scrap processes and product cost glidepaths.

Quality Processes

• Understanding of quality processes.
• Manage manufacturing expectations including CAPAs and non‑conformances.

Business Acumen

• Experience working in a broader enterprise / cross‑division business unit model preferred.
• Ability to work in a highly matrixed and geographically diverse business environment.
• Strong leadership skills, including setting goals and providing constructive feedback to build positive relationships and improve business results.
• Ability to work effectively within a team in a fast‑paced changing environment.
• Strong verbal and written communication skills; ability to communicate at multiple levels.
• Multi‑task, prioritize, and meet deadlines in a timely manner.
• Strong organizational, planning, and follow‑up skills and ability to hold others accountable.

Base pay: N/A. Pay range may vary by location.

Job family: Manufacturing. Division: EP Electrophysiology. Location: Mexico – Queretaro, Avenida FINSA 156, Lote 12. Work shift: Standard. Travel: Yes, 25% of the time. Medical surveillance: Not applicable. Significant work activities: Not applicable.