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Quality Assurance Director Jobs in Puerto Rico (NOW HIRING)

Non Standard 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

$85 - $115/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 ...

Experience in plant quality assurance for aseptic areas focused on controls/techniques/behaviors ... Requests for accommodation related to our application process can be directed to the Kelly Human ...

Specialist QA - 35615

Juncos, PR · On-site

$65 - $95/hr

Position Summary The Specialist QA is responsible for ensuring compliance with quality standards, regulatory requirements, and internal procedures throughout validation, commissioning, qualification ...

This position reports to the Sr. Manager QA Engineering and is part of the Quality Assurance Engineering Team located in Fajardo, Puerto Rico and will be an on-site role. What you will do: Provide ...

This position reports to the Sr. Manager QA Engineering and is part of the Quality Assurance Engineering Team located in Fajardo, Puerto Rico and will be an on-site role. What you will do: Provide ...

This position reports to the Sr. Manager QA Engineering and is part of the Quality Assurance Engineering Team located in Fajardo, Puerto Rico and will be an on-site role. What you will do: * Provide ...

This position reports to the Sr. Manager QA Engineering and is part of the Quality Assurance Engineering Team located in Fajardo, Puerto Rico and will be an on-site role. What you will do: * Provide ...

This position reports to the Sr. Manager QA Engineering and is part of the Quality Assurance Engineering Team located in Fajardo, Puerto Rico and will be an on-site role. What you will do: * Provide ...

This position reports to the Sr. Manager QA Engineering and is part of the Quality Assurance Engineering Team located in Fajardo, Puerto Rico and will be an on-site role. What you will do: * Provide ...

Position Summary The Specialist QA is responsible for supporting Quality and Manufacturing operations through accurate Batch Record Review, documentation compliance, electronic systems management ...

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We are looking candidates with experience within regulated environment for a SR. Quality Assurance Specialist in Hato Rey, Puerto Rico. Requirement: * Bachelor's degree in Engineering in Engineering ...

Direct the planning, staffing, development, and budgeting of the site quality organization. * Ensure effective evaluation, management, communication, and documentation of product safety risks.

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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.

Specialist QA 35669

Inteldot

Juncos, PR • On-site

Full-time

Posted 12 days ago


Key responsibilities

  • Perform on-the-floor review, approval, and tracking of cGMP processes, procedures, testing methods, and documentation.

  • Ensure deviations are investigated, documented, and procedural controls are maintained, including initiating deviation records.

  • Support internal and external audits and inspections, and provide oversight for New Product Introduction (NPI).


Job description

Inteldot has over 15 years in the life sciences industry, with operations across Puerto Rico, the United States, Europe, and Japan. This is a great opportunity for one of our leading clients in Puerto Rico.
Non Standard Shift
Job Description:
Under minimal supervision, support Quality Assurance program by performing a variety of key responsibilities in manufacturing, process validation, regulatory compliance, and quality assurance activities.
Requirements & Qualifications:
  • Demonstrate validated expertise in Quality Systems such as deviations, CAPA, and change control.
  • Exhibit experience in computer systems validation or computer systems quality assurance, particularly with medical devices and/or consulting background technical proficiency.
  • Possess robust knowledge and experience with processes involved in manufacturing and distribution, QA, QAL, and Process Development.
  • Experience with validation of GxP applications, including development of Validation Master Plan, Installation Qualification (IQ), Risk Assessment/GxP assessment, Operational Qualification (OQ), and Performance Qualification (PQ) protocols, test scripts, and completion/summary report approvals per compliance requirements.
  • Validated experience serving as Quality Contact for complex projects involving new products.
  • Validated experience in commissioning and qualification.
  • Strong organizational skills, including the ability to follow assignments through to completion.
  • Enhanced skills in leading, influencing, and negotiating.
  • Demonstrate the ability to interact effectively with regulatory agencies.
  • Solid word processing, presentation, database, and spreadsheet application skills.
  • Strong communication skills in English and Spanish (both written and oral), facilitation, and presentation skills.
  • Proven skill in working independently and effectively interacting with all levels throughout the organization.
  • Advanced data trending and evaluation abilities.
  • Ability to evaluate compliance issues.

Functions:
  • Perform On-the-floor Plant Quality Assurance (PQA) review, approval, and tracking of cGMP processes, procedures, testing methods in manufacturing, documents and records, batch record review, MES, EBR, SAP, EDMQ, DQMS, Trackwise; including but not limited to deviations, CAPAs, and validations.
  • Actively engage in continuous improvement initiatives, programs, and projects.
  • Vigilantly ensure that changes potentially impacting product quality are assessed according to procedures.
  • Certify that deviations from established procedures are investigated and documented per procedures and ensure on-the-floor triage is completed, documented, and current procedural controls are achieved, including ensuring the initiation of deviation records.
  • Ensure that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements.
  • Require strong collaboration and cross-functional partnership to ensure the Quality Management System, Manufacturing, Process Development, Validation, Quality Control, Warehouse, Engineering, Contractors, Environmental, Facilities, and other processes are executed according to established procedures.
  • Serve as a strategic advisor to senior management regarding quality, compliance, supply, and safety risks.
  • Support internal/external audits and inspections as part of the audit/inspection management team, including acting as Quality unit representative as needed.
  • Accountable for adherence to assigned training, permitting execution of required tasks.
  • Champion continuous improvement initiatives and projects.
  • Provide support and oversight for New Product Introduction (NPI).

Education
  • Bachelor's degree in Science or Engineering + 4 years of directly related experience