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Capa Manager Jobs in Puerto Rico (NOW HIRING)

Responsible for managing NC/CAPA closure within established goal. * Monitor and communicate incidents trends. * Review equipment/system Root Cause Analysis investigations and support trend ...

Responsible for authoring investigation reports, execution of corrective actions and managing NC/CAPA closure within established goal. * Monitor and communicate incidents trends. * Review equipment ...

Responsible for authoring investigation reports, execution of corrective actions and managing NC/CAPA closure within established goal. * Monitor and communicate incidents trends. * Review equipment ...

Responsible for authoring investigation reports, execution of corrective actions and managing NC/CAPA closure within established goal. * Monitor and communicate incidents trends. * Review equipment ...

Responsible for authoring investigation reports, execution of corrective actions and managing NC/CAPA closure within established goal. * Monitor and communicate incidents trends. * Review equipment ...

Responsible for authoring investigation reports, execution of corrective actions and managing NC/CAPA closure within established goal. * Monitor and communicate incidents trends. * Review equipment ...

Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services ... Strong understanding of GMP, quality systems (QMS), CAPA, and regulatory expectations; capable of ...

New

... CAPA, or product quality management. * Bilingual: Spanish and English * Soft Skills: Excellent teamwork skills * Shift: 1st, and according to business needs. * Experience in: * Experience in ...

Process Owner

Juncos, PR · On-site

$90 - $130/hr

Experience with CAPA, change control, or deviation management. * Performance Metrics: Familiarity with OEE, SPC, or manufacturing performance metrics. * Manufacturing Systems: Experience with ERP, ...

New

... managing NC/CAPA closure within established goal. 5. Monitor and communicate incidents trends. 6. Review equipment/system Root Cause Analysis investigations and support trend evaluations. Process ...

Investigate and present status of findings associated with audit observations, NCMR's and CAPA ... As the Manager of the Medical Devices, oversees the strategy implementation and operations for ...

Showing results 41-60

Capa Manager information

What does a CAPA manager do?

A CAPA (Corrective and Preventive Action) Manager is responsible for overseeing an organization's CAPA process to ensure compliance with quality and regulatory requirements. They investigate quality issues, identify root causes, and implement corrective and preventive measures to prevent recurrence. CAPA Managers work closely with cross-functional teams to improve processes, maintain regulatory compliance, and enhance overall product or service quality.

What are the key skills and qualifications needed to thrive as a CAPA manager?

To thrive as a CAPA Manager (Corrective and Preventive Action Manager), you typically need a background in quality assurance, strong analytical and problem-solving abilities, and experience with regulatory compliance, often supported by a degree in a science or engineering field. Familiarity with quality management systems (QMS), risk management tools, root cause analysis methodologies (such as 5 Whys or Fishbone diagrams), and industry certifications like Six Sigma or ISO 9001 are highly valued. Outstanding candidates demonstrate excellent communication, leadership, and organizational skills to effectively drive cross-functional teams and ensure timely resolution of quality issues. These skills are crucial for identifying, addressing, and preventing compliance gaps or product issues, thereby maintaining high standards and avoiding costly regulatory penalties.

What are some common challenges a CAPA manager faces, and how are they typically addressed?

One common challenge CAPA Managers face is ensuring timely and thorough investigations into quality issues while coordinating input from multiple departments. Balancing the need for fast resolution with the rigor required for regulatory compliance can be demanding, especially in highly regulated industries like pharmaceuticals or medical devices. Successful CAPA Managers often address these challenges through clear process documentation, effective project management, and fostering strong collaboration among stakeholders. By leveraging root cause analysis tools and maintaining open communication, they help create a continuous improvement culture that benefits both the organization and its customers.

What are popular job titles related to Capa Manager jobs in Puerto Rico?

For Capa Manager jobs in Puerto Rico, the most frequently searched job titles are:

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

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

What cities in Puerto Rico are hiring for Capa Manager jobs?

Cities in Puerto Rico with the most Capa Manager job openings:

Infographic showing various Capa Manager job openings in Puerto Rico as of August 2026, with employment types broken down into 86% Full Time, 13% Part Time, and 1% Contract. Highlights an 87% Physical, 2% Hybrid, and 11% Remote job distribution.

JT678 - QUALITY APPLICATIONS SPECIALISTS

Quality Consulting Group, LLC

Villalba, PR • On-site

$120 - $160/hr

Other

Re-posted 10 days ago


Job description

QUALITY CONSULTING GROUP, a leader inthe pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.

Responsibilities
  • Conducts a compliant validation process for quality information technology systems which requires formal validation documentation (including standard operating procedures) under appropriate federal regulations.
  • Coordinates activities with clients, programmers/developers and operating personnel, domestic and, as appropriate, global.
  • Identifies current and anticipated requirements for compliant computerized operations and suggests methods for the identification, implementation and maintenance of the procedures, actions and documentation necessary to assure compliance according to the appropriate federal and international regulations which govern the user’s applications.
  • Reports on the status of validation activities to fulfill regulatory requirements.
  • Keeps abreast of changing federal and international regulatory requirements, government audit policies, and the availability of current techniques.
Qualifications
  • Bachelor’s degree in Engineer or Science
  • 10+ years of experience in the medical device industry, with a strong background in field corrective actions, CAPA, or product quality management. Solid understanding of FDA regulations (21 CFR Part 820), ISO 13485, EU MDR, and other relevant medical device regulations.
  • Proven experience leading FCA and CAPA processes, ideally within a medical device or regulated industry.
  • Outstanding communication and interpersonal skills, capable of effectively working with cross-functional teams and external stakeholders.
  • Proficiency in Microsoft Office Suite and quality management systems (QMS). Strong technical writing capability
  • Experience in equipment IQ
  • Experience in OQ (Operational Qualification) and PQ (Performance Qualification) and/or process validation
  • Process Validation Lifecylce ( from process characterization, operational qualification to performance qualification)
  • Preferred experience in DOE (with minitab)
  • Computer and software validation CSV
  • SOP Development
  • Change control of Medical Devices
  • 1st shift

Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

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