Operations Director

JOB DESCRIPTION:

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.

MAIN RESPONSIBILITIES

• Highly experienced in Production management
• In addition to the day-to-day managerial function, the role incorporates the strategic and policy development aspects that have medium term consequences on the operation of the function and perhaps impact elements of organization performance
• Key member in the formulation of production strategy, policy and procedures
• Develops and oversees production activities to maximize the use of the organization´s resources and meet established production specifications and schedules
• Oversees manufacturing activities of multiple product lines operating on multiple shifts
• Develops and implements short and long term strategic plans to ensure manufacturing systems are in place to meet business objectives
• Works cross-functionally with R&D, Quality, Clinical, Regulatory and other departments as needed to ensue effective product transitions into production
• Works with Supply Chain management to develop effective, production planning and inventory systems; ensure accurate tracking and accounting of materials and WIP
• Works with Continuous Improvement and Engineering functions to develop effective manufacturing processes capable of meeting quality, cost and supply chain objectives
• Anticipates and resolve highest level issues and conflicts that could impact operations success
• Hires and retains a diverse, highly qualified staff and provides ongoing performance feedback. Sets goals with align to department plans and manages the execution of goals through coaching and mentoring. Maintains a safe and professional work environment
• Supports all Company initiatives as identified by management and in support of Quality Management System (QMS), Environmental Management Systems (EMS), and other regulatory requirements
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains 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)

Manufacturing and Operations :

• Experience in leading manual operations at a large scale
• Knowledge of Med Device products is preferred, but 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 in Training large organizations and achieve ramp ups
• Experience conducting self-inspections in a GMP context based in 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 the ability to set goals and provide positive and constructive feedback respectfully 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 communications with ability to effectively communicate at multiple levels in the organization
• Multi-tasks, prioritizes and meets deadlines in timely manner
• Strong organizational, planning, and follow-up skills and ability to hold others accountable
• Ability to travel approximately 25-50%, including internationally
• Fully bilingual (English & Spanish)

The base pay for this position is

N/A

In specific locations, the pay range may vary from the range posted.

     

JOB FAMILY:

Manufacturing

DIVISION:

EP Electrophysiology

LOCATION:

Mexico > Queretaro : Avenida FINSA 156, Lote 12

ADDITIONAL LOCATIONS:

WORK SHIFT:

Standard

TRAVEL:

Yes, 25 % of the Time

MEDICAL SURVEILLANCE:

Not Applicable

SIGNIFICANT WORK ACTIVITIES:

Not Applicable