Quality Manager

THE COMPANY

Our client, who is a Medical Device leader, is seeking an experienced Quality Manager to join their leadership team for its Tijuana operation. You will lead all quality functions for a specified manufacturing site, dedicated to maintaining product integrity throughout the development and manufacturing processes. Your expertise will be essential in driving continuous improvement initiatives and implementing robust quality management systems. This position requires collaboration across various departments, including research and development, manufacturing, supply chain, engineering, and regulatory affairs, to ensure that our products not only meet but exceed industry standards. As the Quality Manager, you will play a critical role in risk assessment, root cause analysis, and the successful implementation of corrective and preventive actions.

THE POSITION

The Quality Manager is responsible for ensuring that our products meet the highest standards of quality and regulatory compliance.

Essential duties and responsibilities include the following (Other duties may be assigned):

• Lead the transformation and modernization of our quality organization.
• Lead the development and implementation of strategies to ensure product integrity and compliance with all applicable regulatory requirements.
• Elevate the growth and development of operations, processes, and people.
• Oversee and support day-to-day operations across the manufacturing site to ensure production objectives are achieved while upholding or surpassing established quality standards and organizational goals.
• Collaborate with cross-functional teams to ensure quality standards are integrated into all stages of product development and manufacturing.
• Conduct regular reviews and audits of processes, systems, and products to identify areas for improvement.
• Champion root cause analysis and corrective/preventive action (CAPA) programs; drive resolution of product and process non-conformities.
• Establish and monitor key performance indicators (KPIs) to assess operational effectiveness and drive accountability within teams.
• Ensure continuity for product evaluations and troubleshooting.
• Provide strategic oversight and guidance for quality-related laboratory systems and applications, ensuring accurate data integrity.
• Serve as the primary liaison with regulatory agencies, ensuring that all product releases meet compliance standards.
• Implement continuous improvement initiatives utilizing lean manufacturing and continuous improvement methodologies.
• Develop and deliver training programs for staff to foster a culture of quality and compliance across the organization.
• Identify and recruit top talent; manage onboarding and retention.
• Lead and mentor site department Managers and employees to foster a culture of engagement, accountability, and professional development.
• Understanding and experience in implementing statistical process control and digitization.
• Perform other duties as assigned.

THE CANDIDATE

Education and/or Experience Summary:

• Bachelor's degree in Life Sciences, Chemistry, Biomedical Engineering, Quality Management, or a related field; Advanced degree is preferred.
• 10+ years of progressive experience in Quality roles within manufacturing, with at least 4 years in a leadership capacity (required), and/or equivalent combination of education/experience.
• Advanced experience in precision instruments, life sciences, medical devices, or laboratory manufacturing environments (preferred).
• Proven record of accomplishment managing ERP/QMS programs, ensuring compliance with ISO 9001, and where applicable GMP, GLP, and other Government regulations.
• Expert knowledge of CAPA, FMEA, Root Cause Analysis, and risk management tools.
• Strong knowledge of lean manufacturing principles and experience implementing continuous improvement initiatives.
• Exceptional leadership and team management skills, with experience leading quality teams in a fast-paced manufacturing environment.
• Proven experience in developing and managing budgets, reducing costs, and optimizing operational performance.
• Excellent analytical, problem-solving, and project management skills to drive operational success.
• Excellent communication abilities, with a focus on translating technical concepts across diverse internal and external stakeholders in English and Spanish.
• Strong team leadership, conflict resolution, and coaching/mentoring abilities.

Working Conditions

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

• • This leadership role operates in a hybrid structure, involving regular presence in temperature- and humidity-controlled laboratories, active manufacturing plant floors, and warehouse facilities with varying climate conditions.
  • Time will be split between onsite engagement—including walk-throughs, audits, and hands-on technical assessments—and desk-based work involving documentation, data analysis, and digital communication.
  • Work on the plant floor and in laboratory settings may require movement around equipment, standing for extended periods, and compliance with site-specific safety protocols including PPE usage.
  • Warehouse visits may expose the employee to non-standard temperatures, moderate noise levels, and industrial storage areas.
  • Must adhere to all safety protocols, including PPE usage, restricted access zones, and routine monitoring procedures.
  • Standard office activities involve extended computer use, virtual meetings, email correspondence, and communication with internal teams, customers, and regulatory or government agencies.
  • The role demands a proactive presence both on the manufacturing floor and in leadership forums, with the ability to fluidly shift between strategic oversight and operational execution.

Physical Demands
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
The role regularly requires the ability to sit, stand, walk, and use hands and arms to operate office and laboratory equipment. Occasional lifting and movement of materials or equipment weighing up to 25 lbs. (11 kg). Requires the ability to move throughout manufacturing and laboratory areas, including kneeling, crouching, or reaching as needed to conduct inspections, audits, or team training. Vision abilities required include close vision, color vision, and ability to adjust focus for detailed work and computer use.

Travel Requirements

• Local and intracontinental travel up to 15% between California and Mexico and occasional intercontinental trips for global alignment, vendor relations, or strategic initiatives.
• Travel may occasionally require overnight stays and visits to regulatory agencies, supplier/ customer locations, or industry events.

Work Type

This role is expected to be fully onsite with consistent shop-floor presence alongside some office-based strategic work.