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Quality Manager Medical Device Jobs in Puerto Rico

Weil Group, Inc.

Quality Applications Spec

Villalba, PR · On-site

$69K - $90K/yr

TECHNICAL SKILLS Must Have 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 ...

MiniMed

Sr Quality Operations Manager

Juncos, PR · On-site

... medical device industry - this role is for you! Responsibilities may include the following and other duties may be assigned. The Senior Quality Operations Manager, Compliance & Audit engage in daily ...

MiniMed

Sr Quality Operations Manager

Juncos, PR

... medical device industry - this role is for you! Responsibilities may include the following and other duties may be assigned. The Senior Quality Operations Manager, Compliance & Audit engage in daily ...

CYNET SYSTEMS

Quality Engineer

San Juan, PR · On-site

$25/hr

Relevant experience in Quality and/or Compliance, preferably in the medical device industry ... Implements changes through change management system and provides quality engineering impact ...

QRC Group, Inc

PR

$70K - $90K/yr

... medical device manufacturing site. Selected candidates may support QA oversight, protocol review ... Experience with DHF, Risk Management Files, test method validation, sampling plans, SPC, FMEA, or ...

FITS LLC

Sr. Quality Specialist/Engineer

Juncos, PR · On-site

$86K - $117K/yr

Bachelor's Degree in Engineering or Life Sciences and at least five (5) years of experience in Quality activities within the medical device industry. * Bilingual (English & Spanish). * Shift:

Integra LifeSciences

Plant Manager

Anasco, PR · On-site

... quality, customer service, and financials for the Integra Lifesciences medical device manufacturing site. They are responsible for all aspects of safety and security, manufacturing, engineering ...

Integra LifeSciences

Plant Manager

Anasco, PR · On-site

... quality, customer service, and financials for the Integra Lifesciences medical device manufacturing site. They are responsible for all aspects of safety and security, manufacturing, engineering ...

Kelly Services

Quality Engineer

Arroyo, PR · On-site

$69K - $89K/yr

... medical device products throughout the product lifecycle. You will partner with cross-functional ... Lead and support risk management activities, process validation, and design verification in ...

Medtronic

Sr Quality Engineer

Humacao, PR

$89K - $121K/yr

Medical device experience: Experience in medical device or other FDA/ISO-regulated manufacturing ... Formulates, delivers and/or manages projects assigned and works with other stakeholders to achieve ...

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All JobsQuality Medical Device JobsQuality Manager Medical Device JobsQuality Manager Medical Device Jobs in Puerto Rico

Quality Manager Medical Device information

What does a Quality Manager do in the medical device industry?

A Quality Manager in the medical device industry is responsible for ensuring that products meet all regulatory requirements and quality standards throughout their lifecycle. They develop, implement, and monitor quality management systems, oversee internal and external audits, and work closely with manufacturing, engineering, and regulatory teams to maintain compliance with standards such as ISO 13485 and FDA regulations. Their role is critical to ensuring patient safety and product efficacy by preventing defects and ensuring consistent quality.

What are some common challenges Quality Managers face when ensuring compliance in the medical device industry?

Quality Managers in the medical device industry often encounter challenges such as keeping up with evolving regulatory requirements (like FDA, ISO 13485, and MDR), coordinating cross-functional teams to maintain strict quality standards, and managing documentation for audits. They must also address nonconformities quickly and implement corrective and preventive actions to avoid product recalls. Effective communication and strong attention to detail are essential for navigating these challenges while maintaining product safety and regulatory compliance.

What is the difference between Quality Manager Medical Device vs Quality Engineer Medical Device?

AspectQuality Manager Medical DeviceQuality Engineer Medical Device
Primary FocusOversees quality systems, compliance, and team managementDesigns, develops, and implements quality testing and inspection processes
CertificationsISO 13485, Six Sigma, Lead AuditorISO 13485, Six Sigma, Certified Quality Engineer (CQE)
Work EnvironmentManagement, regulatory compliance, cross-department collaborationProduct testing, process improvement, technical analysis
Industry UsageUsed across organizations to ensure overall quality managementUsed in product development and testing phases

The main difference is that the Quality Manager Medical Device focuses on managing quality systems and compliance at a strategic level, while the Quality Engineer Medical Device concentrates on technical testing and process improvements. Both roles require similar certifications and work within the same industry but serve different functions within quality assurance.

What are the key skills and qualifications needed to thrive as a Quality Manager in the Medical Device industry, and why are they important?

To thrive as a Quality Manager in the Medical Device industry, you need a solid background in quality assurance, regulatory compliance (such as ISO 13485 and FDA 21 CFR Part 820), and process improvement, often supported by a relevant degree in engineering or life sciences. Familiarity with quality management systems (QMS), risk management tools (like FMEA), and certifications such as ASQ Certified Quality Auditor (CQA) or Six Sigma are typically required. Strong leadership, attention to detail, and effective communication are vital soft skills for managing teams and ensuring cross-functional alignment. These skills and qualifications are crucial to ensure product safety, regulatory compliance, and the overall success of medical device manufacturing and delivery.
What job categories do people searching Quality Manager Medical Device jobs in Puerto Rico look for? The top searched job categories for Quality Manager Medical Device jobs in Puerto Rico are:
What cities in Puerto Rico are hiring for Quality Manager Medical Device jobs? Cities in Puerto Rico with the most Quality Manager Medical Device job openings:
Quality Manager Medical Device jobs near you
Infographic showing various Quality Manager Medical Device job openings in Puerto Rico as of July 2026, with employment types broken down into 76% Full Time, 15% Part Time, and 9% Contract. Highlights an 91% Physical, 2% Hybrid, and 7% Remote job distribution.
JT678 - QUALITY APPLICATIONS SPECIALISTS

JT678 - QUALITY APPLICATIONS SPECIALISTS

Quality Consulting Group

Villalba, PR • On-site

Temporary

Posted 4 days ago

Job description

QUALITY CONSULTING GROUP, a leader in the 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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