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Quality Systems Manager Jobs in Puerto Rico (NOW HIRING)

Validation & Engineering Group, Inc

PR · On-site

Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services ... Develops and reviews documentation and procedures, and provides automation systems testing and ...

MM Group

Quality Technician - Contract

Guaynabo, PR · On-site

$18 - $24.25/hr

You will manage document control activities, including the review, organization, and maintenance of ... In addition, you will gain valuable exposure to manufacturing and quality systems while working ...

MM Group

Quality Technician - Contract

Guaynabo, PR

$18 - $24.25/hr

You will manage document control activities, including the review, organization, and maintenance of ... In addition, you will gain valuable exposure to manufacturing and quality systems while working ...

Weil Group, Inc

Sr Quality Specialist/Engineer

Juncos, PR · On-site

$86K - $116K/yr

Knowledge/experience of IT systems, integrations with manufacturing equipment Knowledge/experience ... Delivers and/or manages projects assigned and works with other stakeholders to achieve desired ...

Weil Group, Inc

Sr Quality Specialist/Engineer

Juncos, PR

$86K - $116K/yr

Knowledge/experience of IT systems, integrations with manufacturing equipment Knowledge/experience ... Delivers and/or manages projects assigned and works with other stakeholders to achieve desired ...

Weil Group, Inc.

Sr Quality Specialist/Engineer

Juncos, PR · On-site

$86K - $116K/yr

Knowledge/experience of IT systems, integrations with manufacturing equipment Knowledge/experience ... Delivers and/or manages projects assigned and works with other stakeholders to achieve desired ...

Ferrovial

Quality Manager

San Juan, PR

Oversee document control and quality records management through the electronic document management system. * Provide quality onboarding and training to project personnel, promoting quality awareness ...

JC Automation Corp

PR · On-site

$90K - $100K/yr

Compliance & Quality: Ensure projects maintain compliance with GMP, EHSS, quality systems ... Stakeholder Management: Partner with clients, leadership teams, suppliers, and contractors to ...

Validation & Engineering Group, Inc

PR · On-site

This role is responsible for supporting investigations, CAPA activities, change management coordination, GMP documentation review, compliance tracking, and quality system support activities ...

Validation & Engineering Group, Inc

PR · On-site

This role is responsible for supporting investigations, CAPA activities, change management coordination, GMP documentation review, compliance tracking, and quality system support activities ...

Validation & Engineering Group, Inc

PR · On-site

This role is responsible for supporting investigations, CAPA activities, change management coordination, GMP documentation review, compliance tracking, and quality system support activities ...

Validation & Engineering Group, Inc

PR · On-site

This role is responsible for supporting investigations, CAPA activities, change management coordination, GMP documentation review, compliance tracking, and quality system support activities ...

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All JobsQuality Systems JobsQuality Systems Manager JobsQuality Systems Manager Jobs in Puerto Rico

Quality Systems Manager information

What are the key skills and qualifications needed to thrive as a Quality Systems Manager, and why are they important?

To thrive as a Quality Systems Manager, you need strong expertise in quality management principles, regulatory compliance, and process improvement, typically supported by a degree in engineering or a related field. Familiarity with ISO standards (like ISO 9001), quality management software, and certifications such as Six Sigma or ASQ Certified Manager of Quality/Organizational Excellence are commonly required. Leadership, analytical thinking, and effective communication are crucial soft skills for coordinating teams and driving continuous improvement. These skills and qualifications are essential to ensure consistent product quality, regulatory adherence, and overall organizational efficiency.

What does a Quality Systems Manager do?

A Quality Systems Manager is responsible for developing, implementing, and maintaining a company's quality management systems to ensure compliance with industry standards and regulations. They oversee quality assurance processes, conduct audits, and work with different departments to improve procedures and product quality. Quality Systems Managers also manage documentation, train staff on quality standards, and analyze data to identify areas for continuous improvement. Their goal is to ensure that products and services consistently meet customer and regulatory requirements.

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

AspectQuality Systems ManagerQuality Assurance Manager
Primary FocusDeveloping and maintaining quality management systems and processesOverseeing product testing and ensuring quality standards are met during production
CertificationsISO 9001 Lead Auditor, CQEASQ certifications, QA certifications
Work EnvironmentQuality management departments, compliance teamsProduction lines, testing labs
Industry UsageManufacturing, healthcare, aerospaceManufacturing, software, healthcare

While both roles focus on quality, the Quality Systems Manager primarily manages the overall quality management system and compliance, whereas the Quality Assurance Manager concentrates on product testing and ensuring quality during production. Understanding these differences helps in selecting the right career path or hiring the appropriate professional.

What Does a Quality Systems Manager Do?

As a quality systems manager, your primary responsibilities are monitoring the production processes and ensuring factory machinery/goods are within company and industry requirements. Your duties include weighing, sampling, or testing products for quality and functionality. You may also report the results of quality control tests. You monitor the equipment and people involved, and help with the development and implementation of improved management systems. You are also in charge of creating a standard operating procedure for the specific plant where you work. You check that everything is running at full efficiency and the quality of merchandise is standardized.

How does a Quality Systems Manager typically collaborate with cross-functional teams to drive continuous improvement?

A Quality Systems Manager works closely with departments such as manufacturing, engineering, regulatory, and supply chain to ensure that quality standards are consistently met and improved. They often lead or participate in cross-functional meetings to identify process gaps, analyze data, and develop corrective and preventive action plans. Effective communication and project management skills are essential, as the role involves aligning diverse teams toward common quality objectives and facilitating training or audits to support compliance and improvement initiatives.
More about Quality Systems Manager jobs
What are the most commonly searched types of Quality Systems jobs in Puerto Rico? The most popular types of Quality Systems jobs in Puerto Rico are:
What job categories do people searching Quality Systems Manager jobs in Puerto Rico look for? The top searched job categories for Quality Systems Manager jobs in Puerto Rico are:
Quality Systems Manager jobs near you
Infographic showing various Quality Systems Manager job openings in Puerto Rico as of May 2026, with employment types broken down into 82% Full Time, 15% Part Time, and 3% Contract. Highlights an 94% Physical, 2% Hybrid, and 4% Remote job distribution.

Investigation/CAPA Specialist

Mirus Consulting Group

Humacao, PR • On-site

Other

Posted 27 days ago

Job description

mirus Consulting Group is a local company based in Humacao, Puerto Rico that provides computer system validation and information technology consulting services to pharmaceutical companies and other organizations across the Island and parts of the United States. Its services include the assessment and validation of automation equipment, network infrastructures and business processes, as well as the project management involved.
Position Overview
The Investigation / CAPA Specialists to support Quality Systems and Manufacturing Operations within a highly regulated medical device manufacturing environment. These resources will play a critical role supporting deviation investigations, nonconformance management, root cause analysis, CAPA development, and quality system compliance activities associated with manufacturing, engineering, and operational processes. The candidates will work cross-functionally with Manufacturing, Quality Assurance, Engineering, Supply Chain, and Operations teams to ensure timely closure of investigations and implementation of sustainable corrective and preventive actions aligned with FDA and ISO regulatory expectations.
Key Responsibilities
Investigations & Quality Events
  • Lead and support investigations related to:
    • Nonconformances (NCs)
    • Deviations
    • CAPAs
    • Customer complaints
    • Manufacturing events
    • Process excursions
    • Equipment and documentation discrepancies
    • Perform detailed root cause analysis using methodologies (such as...5 Whys, Fishbone / Ishikawa, Fault Tree Analysis, Risk Assessments, Trend Analysis ...)
  • Ensure investigations are properly documented, technically justified, and closed within established timelines.
CAPA Management
  • Develop, implement, and track Corrective and Preventive Actions (CAPAs).
  • Evaluate CAPA effectiveness and sustainability.
  • Collaborate with cross-functional teams to ensure corrective actions address systemic issues.
  • Monitor CAPA metrics and identify recurring trends impacting quality performance.
Documentation & Compliance
  • Author and review investigation reports, CAPA records, technical assessments, and quality documentation.
  • Support documentation activities within electronic quality management systems (eQMS).
  • Ensure compliance
  • Support audit readiness initiatives and participate in internal/external audits.
Cross-Functional Collaboration
  • Partner with Manufacturing, Engineering, Validation, and Operations teams to evaluate process impact and implement corrective strategies.
  • Participate in risk assessments and continuous improvement initiatives.
  • Support escalation meetings and quality review boards when required.
  • Provide technical support during regulatory inspections and quality audits.
Required Qualifications
  • Bachelor's Degree in: Engineering, Chemistry, Microbiology, Life Sciences, Industrial Sciences or Related Technical Discipline.
  • Minimum:
    • 3 - 5 years of experience
  • Experience in Medical Device, Pharmaceutical, Biotechnology and FDA-regulated manufacturing environments.
Preferred Qualifications
  • Strong experience managing: Investigations, Deviations, Nonconformances and CAPA systems.
  • Hands-on experience with root cause analysis methodologies.
  • Experience using quality systems such as: TrackWise, Infinity, SAP, MasterControl, ETQ or Similar eQMS platforms.
  • Knowledge of: FDA regulations, ISO 13485, GMP requirements and Data Integrity principles.
  • Strong technical writing and documentation skills.
  • Experience supporting audit readiness and inspection support activities.
Key Technical Skills
  • Root Cause Analysis
  • CAPA Management
  • Investigation Writing
  • Nonconformance Management
  • Quality Systems
  • GMP Compliance
  • Risk Assessments
  • Technical Documentation
  • Problem Solving
  • Cross-Functional Coordination
  • Data Trending & Analysis
This Company is an equal employment opportunity employer. We adhere to a policy of making employment decisions without regard to race, color, religion, sex, sexual orientation, national origin, citizenship, age or disability. We assure you that your opportunity for employment with this Company depends solely on your qualifications.

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