Quality Assoc Director

What You Can Expect

Zimmer Biomet is seeking a Quality Associate Director to lead the Quality function for a new greenfield manufacturing site in Costa Rica. This role will establish and lead the site Quality organization, implement the Quality Management System, and ensure compliance with applicable global regulations and standards supporting medical device manufacturing and global distribution.This leader will play a key role in building a quality-first culture, shaping foundational processes and team capabilities, and supporting successful site start-up, regulatory readiness, operational excellence, and long-term growth.

The Quality Associate Director is responsible for directing the quality assurance processes and ensuring compliance with the FDA Quality System Regulations, ISO 13485 Quality System Standard, MDD, CMDR, JPAL, and other applicable regulations. The Quality Director is responsible for implementing and driving key metrics in the quality assurance processes and for developing effective strategies to ensure the continuous improvement and effectiveness of the Quality System.

The Quality Manager collaborates with business leaders and their teams to ensure that quality and manufacturing practices, organizational structure, and management procedures are at the optimum level to drive and support the achievement of business objectives.This role has full accountability for the achievement of all functional objectives and related tasks across the site. Direct reports may include Quality managers, engineers, and technicians, Regulatory Affairs personnel, inspectors, auditors, lab personnel, and microbiologists.

This position is on-site 5 days per week. 

How You'll Create Impact

• Lead the implementation of the Quality Management System (QMS), ISO certifications, and regulatory requirements for medical device manufacturing and global distribution.
• Serve as the site Quality Management Representative and oversee daily Quality operations.
• Manage quality control activities, including CAPAs, ensuring effective and sustainable solutions.
• Define quality assurance requirements based on technical specifications, regulatory, and industry standards.
• Develop and maintain procedures, standards, and inspection methods to ensure product quality.
• Ensure compliance with GMP, calibration programs, and control of nonconforming products.
• Implement defect prevention strategies (SPC/SQC) and drive continuous improvement initiatives.
• Develop data analysis, reporting systems, and insights to support regulatory compliance and decision-making.
• Lead, develop, and retain talent, fostering a high-performance and continuous improvement culture.
• Manage budgets and support Lean Manufacturing, Six Sigma, and business continuity initiatives.
• Collaborate cross-functionally to ensure compliance, employee engagement, and organizational development.
• Ensure adherence to all applicable regulations and corporate standards.
•  

This is not an exhaustive list of duties or functions and might not necessarily comprise all the essential functions of the position. The employee may perform other related duties as negotiated to meet the ongoing needs of the organization.

What Makes You Stand Out

• Strong knowledge of FDA Quality System Regulations, ISO 13485, and other global regulatory frameworks (MDD, CMDR, JPAL).
• Proven ability to interpret and apply quality standards for global manufacturing and distribution environments.
• Experience leading large-scale, high-impact transformation and continuous improvement initiatives.
• Solid project management and oversight capabilities.
• Excellent communication and presentation skills, with the ability to convey complex concepts clearly to diverse audiences.
• Strong interpersonal, negotiation, and conflict resolution skills, with the ability to influence stakeholders at all levels.
• Highly collaborative, with the ability to quickly build relationships across functions and teams.
• Strong organizational and time management skills, with attention to detail and ability to manage multiple priorities.
• Demonstrated initiative, accountability, and problem-solving skills in dynamic and ambiguous environments.
• Advanced knowledge of statistical tools, data analysis, and quality methodologies.
• Financial acumen with a solid understanding of key financial concepts.
• High level of integrity, ownership, and results-driven mindset.
• Proficiency in Microsoft Office and ability to quickly learn new systems (including internal platforms).
• Up-to-date knowledge of industry best practices, regulatory requirements, and emerging technologies.
• Fluency in English required; Bilingual with ability to read, write, and speak English and Spanish fluently required.

Your Background

Minimum Requirements:

• Bachelor’s degree in a quality-related or technical field required; Master’s degree preferred.
• Minimum of 8 years of relevant experience; 12+ years preferred (or required without a bachelor’s degree).
• Equivalent combinations of education and experience may be considered.
• Strong background in quality systems and leadership within complex organizations.
• Experience in regulated manufacturing environments required.
• Medical device industry experience strongly preferred.
• Proven leadership and people management experience.
• Relevant technical certifications or specialized training preferred.
• Lean and/or Six Sigma certification is a plus.

Travel Expectations

Increased travel may be required during site development, staffing, and preparation for initial production.

Note: This role is based at the Green Valley manufacturing plant in Costa Rica

Onsite 100% In-person attendance will be required as need it with some flexibility when need it.