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Quality Assurance Director Jobs in Puerto Rico (NOW HIRING)

Quality Assurance

Carolina, PR · On-site

$48 - $72/hr

Quality Assurance Specialist en Prosolar es responsable de garantizar que todos los procesos, instalaciones y proyectos solares cumplan con los más altos estándares de calidad, seguridad y ...

Quality Assurance

Carolina, PR · On-site

$52 - $78/hr

Quality Assurance Specialist en Prosolar es responsable de garantizar que todos los procesos, instalaciones y proyectos solares cumplan con los más altos estándares de calidad, seguridad y ...

The Specialist QA performs a broad range of Quality Assurance activities under minimal supervision, ensuring compliance with cGMP requirements, internal procedures, and regulatory expectations. This ...

SUMMARY Perform one or more of the following duties and responsibilities in support of Amgen's Quality Assurance program under minimal supervision. FUNCTIONS - Review and approve product MPs ...

Specialist QA

Juncos, PR · On-site

$90 - $120/hr

Specialist QA FUNCTIONS * Review and approve product MPs. * Approve process validation protocols and reports for manufacturing processes. * Request Quality on incident triage team. * Approve ...

Learn more at We are searching for the best talent for Quality Assurance Technician. Purpose ... be directed to your accommodation resource. If you are under 18 years of age you (the candidate ...

QA Specialist

Aguadilla, PR · On-site

$52 - $76/hr

Implement and maintain QA QC procedures and protocols. * SCAR (Supplier Corrective Action Request): Gathering data on supplier defects, assisting in investigations, and verifying corrective actions.

New

QA Specialist- ProQN669

Juncos, PR · On-site

$65 - $90/hr

Position Summary Our client is seeking a QA Specialist to support its Quality Assurance program with minimal supervision. The successful candidate will provide on-the-floor Quality Assurance support ...

Position Summary The QA Specialist is responsible for ensuring product quality, process compliance, and continuous improvement within manufacturing or service delivery operations. This role combines ...

Administrative Shift Under minimal supervision, support Quality Assurance program by performing a variety of key responsibilities in manufacturing, process validation, regulatory compliance, and ...

Specialist QA- 35670

Juncos, PR · On-site

$65 - $90/hr

Represent QA on NPI team. * Lead investigations. * Lead site audits. * Own site quality program procedures. * Designee for QA manager on local CCRB. * Review Risk Assessments. * Support Automation ...

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Quality Assurance Director information

What does a Quality Assurance Director do?

A Quality Assurance Director oversees the development and implementation of quality standards and processes within an organization. They lead teams responsible for inspecting, testing, and ensuring that products or services meet regulatory and company requirements. Their responsibilities also include establishing quality control policies, analyzing data to identify trends or issues, and driving continuous improvement initiatives. In many organizations, they serve as the main liaison between management, production, and regulatory bodies to ensure compliance and customer satisfaction.

What does a Quality Assurance Director do?

As a quality assurance director, you oversee the quality control process at your company and ensure processes and products meet the standards set by organizations like the American Society for Quality (ASQ). In this role, you may help products obtain a quality certification, use statistics to watch for problems with product production lines, and talk with customers to get more information about their experience using the product. Fulfilling the responsibilities and duties of a quality assurance director requires interpersonal skills, leadership skills, a willingness to strive for perfection, and sometimes the ability to work outside of normal hours if the company detects an urgent problem with its products.

What are the key skills and qualifications needed to thrive as a Quality Assurance Director?

To thrive as a Quality Assurance Director, you need expertise in quality management systems, regulatory compliance, and process improvement, often backed by a bachelor’s or master’s degree in a relevant field. Familiarity with tools such as ISO standards, Six Sigma methodologies, and quality management software is crucial. Strong leadership, strategic thinking, and excellent communication skills set top performers apart in this role. These competencies ensure product quality, regulatory adherence, and continuous improvement, directly impacting organizational reputation and operational efficiency.

How does a Quality Assurance Director typically collaborate with cross-functional teams to ensure product quality?

A Quality Assurance Director works closely with departments such as product development, engineering, regulatory affairs, and operations to establish quality standards and processes. They lead regular meetings to align on quality goals, review performance metrics, and address any quality-related issues or risks. This collaborative approach helps to ensure that quality is integrated into every stage of the product lifecycle, from design to delivery. By fostering open communication and teamwork, the director ensures all teams are accountable for maintaining high standards and meeting compliance requirements.

What is the difference between Quality Assurance Director vs Quality Control Manager?

AspectQuality Assurance DirectorQuality Control Manager
CredentialsTypically requires a bachelor’s degree in quality management, engineering, or related field; certifications like ASQ CQE or CQA are commonUsually holds a bachelor’s degree in quality, manufacturing, or engineering; certifications like ASQ CQE are also valued
Work EnvironmentOversees quality assurance processes across departments, focusing on system improvements and complianceManages day-to-day inspection and testing activities to ensure product quality
Industry UsageUsed in manufacturing, software, healthcare, and industries emphasizing process qualityCommonly found in manufacturing, production, and assembly lines

The Quality Assurance Director focuses on establishing and maintaining quality systems and processes, ensuring compliance and continuous improvement. In contrast, the Quality Control Manager concentrates on inspecting products and identifying defects during production. Both roles are essential for quality management but differ in scope and responsibilities.

What are the most commonly searched types of Quality Assurance jobs in Puerto Rico?

The most popular types of Quality Assurance jobs in Puerto Rico are:

What job categories do people searching Quality Assurance Director jobs in Puerto Rico look for?

The top searched job categories for Quality Assurance Director jobs in Puerto Rico are:

What cities in Puerto Rico are hiring for Quality Assurance Director jobs?

Cities in Puerto Rico with the most Quality Assurance Director job openings:

Infographic showing various Quality Assurance Director job openings in Puerto Rico as of August 2026, with employment types broken down into 1% As Needed, 81% Full Time, 14% Part Time, 3% Contract, and 1% Nights. Highlights an 91% Physical, 1% Hybrid, and 8% Remote job distribution.

Director, Quality Assurance & Regulatory Compliance

CooperCompanies

Juana Diaz, PR • On-site

Full-time

Posted 3 days ago

New


Job description


At CooperVision, a business unit of CooperCompanies (Nasdaq: COO), we're driven by a unified purpose of helping people experience life's beautiful moments. We are connected through our shared values - dedicated, innovative, friendly, partners, and do the right thing. As a leading global manufacturer of contact lenses, we are committed to helping improve the way people see each day. Through our diverse lens portfolio, we tackle the toughest vision challenges - including astigmatism, presbyopia, and childhood myopia. We offer the most complete collection of spherical, toric, and multifocal products available, enabling us to fit 99% of all contact wearers. Learn more at www.coopervision.com
  • This position requires full-time onsite work (5 days per week) in Juana Diaz, P.R.

Responsibilities
Job Summary:
This role is responsible for ensuring Puerto Rico Manufacturing Operations produces and releases contact lenses in compliance with the Global CooperVision Quality Management System, applicable medical device regulations, industry standards, and market-specific requirements.
This role serves as the designated Quality Management Representative for the Puerto Rico Manufacturing Operations and is accountable for the effectiveness, compliance, and continuous improvement of the site Quality Management System. The position is a critical member of both the Global Quality Assurance Operations and Puerto Rico Manufacturing Operations leadership teams, providing strategic quality leadership and regulatory oversight to support business objectives and patient safety.
This role is responsible for ensuring Puerto Rico Manufacturing Operations produces and releases contact lenses in accordance with the Global CooperVision Quality Management System, medical device standards, and applicable regulations for all markets where CooperVision products are sold.
Qualifications
Essential Functions & Accountabilities:
  • Lead the QA department to ensure manufacturing processes produce contact lenses that meet CooperVision's specifications, customer and external regulatory requirements
  • Drive the Strategic Quality plans through leadership and across the manufacturing site.
  • Lead and oversee all regulatory inspections, certification audits, customer audits, and corporate quality assessments, ensuring organizational readiness, effective inspection management, and timely resolution of observations and commitments.
  • Responsible for ensuring all contact lenses meet the required release criteria including sterility, safety, efficacy and labeling
  • Develop, implement and oversee meaningful QA performance metrics that support both Global Quality and business goals, ensuring alignment with the Global Scorecard and enterprise strategic priorities.
  • Advise and guide leadership and Senior Operations Managers on QA-related issues that could affect the production or non-release of products.
  • Develop the capability of the QA function and ensure that talent management and succession planning provide for the future needs of the business.
  • Serve as the primary Quality leader and escalation point for significant product quality issues impacting products manufactured at the Puerto Rico site, ensuring timely investigation, decision-making, risk assessment, and resolution in partnership with Global Quality.
  • Ensure effective escalation management and tools for corrective and preventive activities, including NCR, CAPA, HHE, change control, validations and audits.
  • Leads and drives the application of effective problem-solving and root cause analysis methodologies to resolve quality issues, prevent recurrence, and support continuous improvement.
  • Heads QA projects to develop functional capability on delivering a QMS that enables the changing needs and technology of PRMO in harmony with CooperVision global objectives.
  • Direct the Management Review process and participate as required for the PRMO and regional/global business management reviews within CooperVision.
  • Promote management's commitment to the development, implementation, and ongoing effectiveness of the Quality Management System by communicating the importance of meeting customer, statutory, and regulatory requirements throughout the organization.
  • Actively participate in the Operational Excellence programs, including their forums and activities, while promoting and supporting the culture of continuous improvement within the organization.
  • Establish stretch goals and monitor results and budget, demonstrating financial acumen.
  • Lead, coach, and develop a high-performing Quality organization by fostering a culture of accountability, inclusion, innovation, continuous improvement, and regulatory excellence.
  • Build organizational capability through talent reviews, succession planning, workforce planning, and leadership development initiatives.
  • Establish clear performance expectations, provide ongoing coaching and feedback, and develop future leaders to ensure organizational readiness and business continuity.
  • Ensure site compliance with applicable FDA, ISO 13485, MDSAP, MDR, and other global regulatory requirements, maintaining a state of continuous inspection readiness.
  • Partner with Regulatory Affairs and Global Quality teams to assess the impact of changing regulations and ensure timely implementation of required actions.

Quality System Responsibilities
  • Lead and maintain the site Quality Management System (QMS), ensuring compliance with applicable regulatory requirements, industry standards, and company policies.
  • Provide Quality oversight for manufacturing and quality system processes, including product release, nonconformance management, CAPA, change control, validation, and risk management activities.
  • Ensure continuous inspection and audit readiness, representing the site during regulatory inspections, customer audits, and corporate assessments, and driving effective resolution of quality issues.
  • Establish a culture of quality and continuous improvement by monitoring quality performance, developing organizational capability, and communicating quality risk and trends to site and executive leadership.

Qualifications
Knowledge, Skills, and Abilities:
  • Demonstrated knowledge and application experience of ISO13485, FDA Quality Management System Regulation (21 CFR Part 820) and related regulations, as well as knowledge in all major manufacturing processes and support systems.
  • Extensive experience in management and ownership of complex problem resolution, including CAPA, 3rd party inspections, including Notified Body and FDA responses to inspection findings and deficiencies.
  • Demonstrated excellent communication skills (oral and written) with all levels of management in both English and Spanish.
  • Computer literate with a working knowledge of software programs such as Microsoft Office
  • Excellent organizational skills; able to handle, organize, and follow up on multiple priorities.
  • Attracts and retains high-caliber talent.
  • Builds an inclusive, engaged culture that values diverse backgrounds and perspectives.
  • Model high integrity and live the organizational values.
  • Proven capability to develop high-performing teams and maintain a culture of Quality and Continuous Improvement.
  • Needs to have high analytical capacity and a level of professionalism and judgment to resolve problems.
  • Must be a team player. Must be able to work under pressure.

Experience:
  • 10+ years of progressive Quality leadership experience within a regulated industry.
  • Minimum 5 years leading managers and/or multiple Quality functions.
  • Experience serving as Management Representative or equivalent quality leadership role during regulatory inspections.

Education:
  • Bachelor's degree in sciences, engineering, or related field.

We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status. We are proud to be an equal opportunity workplace.
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About Us
CooperVision is a global leader in the contact lens industry, dedicated to helping improve the way people see every day. Achieving that goal takes the collaboration of team members with wide-ranging skills; from scientists and researchers, to manufacturing and operations experts, to sales and marketing professionals.
At CooperVision, our effort to improve lives begins with our employees. We are committed to developing people as a key global differentiator and our most important asset. We empower employees to succeed, rewarding great thinking and hard work with competitive pay, comprehensive benefits, and with a special focus on wellness. Our commitment to our core values and an employee-centric culture fuel a deeply engaged, high performing organization.
CooperVision employees pride themselves on being proactive, innovative, flexible and friendly. That's a strong reflection of our corporate culture-and part of the reason CooperVision may be a great workplace for you.