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Global Quality Manager Jobs in Puerto Rico (NOW HIRING)

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Global Quality Manager information

What does a global quality manager do?

A Global Quality Manager is responsible for overseeing and managing quality assurance and control processes across multiple countries or regions within an organization. Their role involves developing global quality standards, ensuring compliance with local and international regulations, and leading initiatives to improve product or service quality. They coordinate with various teams to implement best practices, conduct audits, and address quality issues. The goal of a Global Quality Manager is to ensure consistency, efficiency, and high standards throughout all operations worldwide.

How does a global quality manager typically coordinate quality standards across multiple international sites?

A Global Quality Manager often collaborates closely with regional quality teams to ensure consistent implementation of company-wide standards while adapting to local regulatory requirements. This involves regular virtual meetings, cross-site audits, and developing unified documentation systems to track compliance and performance. Effective communication and cultural awareness are essential, as the role requires bridging differences in processes and expectations across various countries. Additionally, the Global Quality Manager may lead global training initiatives and facilitate best practice sharing among sites.

What are the key skills and qualifications needed to thrive as a global quality manager, and why are they important?

To thrive as a Global Quality Manager, you need expertise in quality management systems, regulatory compliance, and process improvement, often supported by a degree in engineering or a related field. Familiarity with standards such as ISO 9001, Six Sigma certification, and proficiency in quality management software are typically required. Strong leadership, cross-cultural communication, and problem-solving abilities help drive global quality initiatives and foster collaboration across diverse teams. These skills and qualities are crucial for maintaining consistent product or service quality, meeting international standards, and ensuring customer satisfaction worldwide.

What is the difference between Global Quality Manager vs Quality Assurance Manager?

AspectGlobal Quality ManagerQuality Assurance Manager
CertificationsISO 9001, Six Sigma, ASQ certificationsISO 9001, Six Sigma, ASQ certifications
Work EnvironmentInternational, multi-site, corporate levelDepartmental, site-specific, operational level
Industry UsageManufacturing, automotive, aerospace, global companiesManufacturing, software, healthcare, local or regional companies
Primary FocusOverseeing quality standards across multiple regions and ensuring global complianceImplementing quality processes and ensuring product quality at specific sites

The Global Quality Manager typically manages quality standards across multiple regions and ensures compliance on a global scale, requiring broader strategic oversight. In contrast, the Quality Assurance Manager focuses on implementing and maintaining quality processes within specific departments or sites. Both roles require similar certifications but differ mainly in scope and geographic focus.

What job categories do people searching Global Quality Manager jobs in Puerto Rico look for?

The top searched job categories for Global Quality Manager jobs in Puerto Rico are:

What cities in Puerto Rico are hiring for Global Quality Manager jobs?

Cities in Puerto Rico with the most Global Quality Manager job openings:

Director, Quality Assurance & Regulatory Compliance

CooperCompanies

Juana Diaz, PR • On-site

Full-time

Posted 2 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.