Director Quality Operations, Ophthalmology

Our mission
At Corza Medical, our mission is to champion surgical providers with remarkable service and exceptional products that save time, money, and effort. We are a passionate team guided by our core belief that you should never have to choose between performance, value, and a quality customer experience. We are here to support you every step of the way.

Our brand promise
We deliver a collaborative experience by working directly with the surgical community to ensure you get the exact surgical tools you need at the right time and the right price.

• Remarkable service: A seamless, personal process designed around you and your needs.
• Trusted performance: Our product family is the result of years of experience championing surgeons and listening to their expertise.
• Outstanding value: No matter the surgical specialty, we deliver quality products for all markets.

Our people promise
Excellence is our Specialty and what makes us successful is our people. We are committed to fostering a positive, empowering and growth-oriented environment where all team members are encouraged to share their opinions and ideas. That means you will work alongside an accomplished and highly collaborative team that inspires commitment to our goal in attaining excellence in everything they do.

Job Purpose Summary

• The Director of Quality Operations is responsible for overseeing quality assurance and compliance across manufacturing and distribution sites in the U.S. and U.K. This role ensures that all products meet regulatory, customer, and internal quality standards while maintaining alignment with global regulatory requirements, including FDA, ISO 13485, and MHRA. Reporting to the Vice President of Quality Assurance and Regulatory Affairs, the Director drives operational excellence, fosters a culture of continuous improvement, and ensures effective quality system management to support business objectives and regulatory compliance.

What you will do

• Oversee the implementation and maintenance of quality management systems (QMS) across U.S. and U.K. manufacturing and distribution operations to ensure compliance with FDA, ISO 13485, MHRA, and other applicable regulations.
• Lead quality operations teams at multiple sites, ensuring alignment of quality processes and continuous improvement initiatives.
• Develop and execute strategies for quality assurance, risk management, and compliance to enhance operational efficiencies and regulatory adherence.
• Ensure timely resolution of quality issues, including non-conformances, complaints, and CAPA management.
• Support and oversee regulatory inspections, internal and external audits, and supplier quality programs.
• Collaborate with manufacturing, supply chain, and engineering teams to integrate quality into all aspects of product development and production.
• Develop key performance indicators (KPIs) to track quality performance, identify trends, and drive improvement initiatives.
• Ensure effective training programs are in place to maintain a high level of quality awareness and compliance among employees.
• Partner with cross-functional teams to optimize processes, reduce defects, and improve product reliability.
• Serve as the primary point of contact for quality operations at manufacturing and distribution sites, escalating critical quality issues as needed.

What you will need
Education:

• Bachelor’s degree in engineering, life sciences, or a related field; an advanced degree is preferred.

Experience:

• Minimum of 10 years of leadership experience in quality assurance and regulatory affairs within a global medical device or world-class manufacturing environment. Proven track record in regulatory compliance, quality systems management, and cross-functional leadership.
• Strong knowledge of U.S. FDA regulations (21 CFR 820), ISO 13485, MHRA requirements, and global medical device quality standards.
• Experience managing quality operations in both manufacturing and distribution environments.
• Proven leadership experience in managing and developing quality teams across multiple sites.

Other Knowledge, Skills, Abilities or Certifications:

• Expertise in quality management systems, risk management, and process validation in a medical device manufacturing setting.
• Strong analytical skills to assess quality trends and implement corrective actions.
• Excellent communication and leadership skills, with the ability to influence cross-functional teams and senior management.
• Experience with Lean, Six Sigma, or other continuous improvement methodologies in a regulated environment.
• Proficiency in statistical analysis tools and applications for quality control.
• Relevant certifications such as ASQ CQE, CQA, or Six Sigma Green/Black Belt preferred.
• Ability to travel between U.S. and U.K. sites as needed.
• Ability to communicate effectively at all levels of the organization, influencing stakeholders, including executive leadership.

What we value

• Customer First - We deliver extraordinary experiences.
• Accountability - We do what we say.
• Integrity - We do what is right.
• Inspired - We love what we do.
• One Global Team -We before me, always.

What you will like
We foster a work environment where all team members are empowered and encouraged to share their opinions and ideas. We encourage robust, fact-based debate. Our highly collaborative work environment results in the best decisions for Corza Medical and a shared mission to execute our plan together, on time and on budget.

Join our team.
At Corza Medical, we are motivated by enabling our customers’ success. That starts with understanding their needs and developing products that enhance clinical outcomes. Our goal is to provide innovative, high-quality products and services that will ensure the continued success of our company and surgical professionals well into the future.

A reasonable estimate of the current pay range for this role is $150,000 - $175,000. Further, pay that is offered is based on geographic location, internal equity, market data, applicant’s job-related skills, commensurate experience, required licensures, certifications and certain degrees.

Corza Medical offers a competitive benefits package including medical, 401K, vacation and sick time, paternal leave and other benefits.

Corza Medical is an equal opportunity employer. Corza Medical evaluates qualified applicants without regard to race, color, marital status, religion, sex, sexual orientation, gender identity, age, national origin, physical or mental disability, veteran status or other protected characteristics.