Top 179 Medical device validation Jobs in Carolina, Pr

Calibration & Metrology Laboratory Manager
Confidential —San Juan, PR
- From $45,000 a year
- Full-time
- Spanish
- Engineering
- Data analysis skills
- Paid holidays
- Health insurance
Quick Apply
11h
Validation Quality Engineer
Pharma-Bio Serv —Dorado, PR
- Contract
- Background check
- Spanish
- Engineering
Quick Apply
13d
Process Engineer - I
Weil Group, Inc —Humacao, PR
- Temporary
- Bilingual
- Background check
- Engineering
Quick Apply
Computer System Validation Engineer - Medical Device Equipment & Regulations
Macpower Digital Assets Edge Private Limited —San Juan, PR
- $45 an hour
- Organizational skills
- Software development experience
- Senior level
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Manufacturing Document Clerk
Mentor Technical Group —Carolina, PR
- Full-time
- Mid-level
- Office
- Organizational skills
Manufacturing Engineer I (Entry Level)
CIS International LLC —Municipio de Juncos, PR
- Spanish
- Microsoft Excel
- Engineering
Quick Apply
Sr. Validation Specialist with Bachelor Degree in Science or Engineering
Validation & Engineering Group —San Juan, PR
- Computer literacy
- Engineering
- Assembly
Quick Apply
Commissioning, Qualification & Validation Specialist (CQV)
Cencora —Juncos, PR
- Full-time
- Engineering
- Mid-level
- 2 years
- Paid parental leave
- Health insurance
Validation and CSV Lead Engineer (Validation Lead - Capital Automation Projects)
Macpower Digital Assets Edge Private Limited —San Juan, PR
- $51 an hour
- Management
- Analysis skills
- Mentoring
Quick Apply
Environmental Monitoring and Sampling Coordinator Non Standard Shift
Mentor Technical Group —Juncos, PR
- Weekends as needed
- Microsoft Excel
- Microsoft Outlook
- Basic math
- COVID-19 protective measures
Jr. Validation Specialist
Mirus Consulting Group —Humacao Municipio, PR
- Spanish
- English
- Mid-level
Quick Apply
Env. Monitoring & Sampling Technician
MENTOR TECHNICAL GROUP CORP —Municipio de Juncos, PR
- Weekends as needed
- Microsoft Excel
- Microsoft Outlook
- Basic math
- COVID-19 protective measures
Quick Apply
Jr. Validaiton Specialist - Autoclave
EB Validation Services —Caguas, PR
- Contract
- Engineering
- Cleaning
- In-person
Quick Apply
1d
Manufacturing Technician
Weil Group, Inc —Dorado Municipio, PR
- Overtime
- Mid-level
- 3 years
- Associate's degree
Quick Apply
Process Engineer
QRC Group, Inc —Carolina, PR
- Contract
- Spanish
- Engineering
- English
Quick Apply
14d
Sr. CSV Specialist/ Lab Equipment Qualification
Mentor Technical Group —Carolina, PR
- Full-time
- Spanish
- Computer Science
- 5 years
Validation Engineer - Upstream
Validation & Engineering Group, Inc —Carolina, PR
- Extended hours
- Engineering
- Mid-level
- 3 years
Quick Apply
Mechanic Operator
West Pharmaceutical Services —Cidra, PR
- Overtime
- Background check
- Spanish
- Microsoft Outlook
Validation Engineer
Validation & Engineering Group —Juncos, PR
- Extended hours
- Engineering
- 8 years
- Programmable logic controllers
Quick Apply
Manufacturing Engineer I (Entry Level- 2nd Shift)
CIS International LLC —Juncos, PR
- Full-time
- Spanish
- Engineering
- English
Quick Apply
7d

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medical device validation jobs near carolina, pr

Calibration & Metrology Laboratory Manager

Confidential
San Juan, PR

Quick Apply

Job Details

Full-time
From $45,000 a year
11 hours ago

Benefits

Paid holidays
Health insurance
Dental insurance
401(k)
Vision insurance

Qualifications

Statistics
Document compliance management
ASTM standards
ISO certification process
Spanish
Customer communication
Team leadership
Quality control statistical data analysis
Spreadsheets
Dimensional inspection
Data analysis skills
Project coordination
Laboratory information management systems
English
GMP
Electrical instrumentation
Team development
Dimensional measurements
Driver's License
Supervising experience
Laboratory quality control records management
Bachelor's degree
Attention to detail
Pharmaceutical company experience
ASME codes & standards
Laboratory budgeting
Regulatory compliance analysis
General management
Organizational budget management
Data analysis software

Full Job Description

A leader company in industrial weighing, instrumentation, and metrology is seeking an experienced Calibration & Metrology Laboratory Manager to lead the day-to-day operation of our calibration laboratory and help drive its continued growth. Puerto Rico is home to one of the densest concentrations of pharmaceutical, medical-device, and aerospace manufacturing in the world, and our lab keeps the instruments behind that industry accurate, traceable, and audit-ready.

This is a role for a true metrologist who is just as comfortable building an uncertainty budget and hosting an accreditation assessment as picking up a multimeter and running a calibration when the bench gets busy. You will own the technical and operational performance of the lab, mentor the technical team, and serve as our primary point of contact for the measurement needs of our customers. We are open to senior Calibration Technicians and Metrologists ready to step into a leadership role, as well as experienced lab managers. The right person adapts to the needs of the business and grows with it.

Key Responsibilities

Lead lab operations: Plan daily workloads, schedule calibrations, and optimize turnaround times while maintaining quality and on-time delivery.
Lead the calibration, validation, and maintenance of laboratory instruments and equipment in accordance with regulatory standards and internal protocols
Perform calibrations when needed: Conduct calibrations across multiple disciplines to support the team, cover demand, and keep the lab running smoothly.
Own the management system: Maintain and continuously improve the laboratory’s ISO/IEC 17025:2017 management system — document and records control, internal audits, corrective and preventive actions, management review inputs, and risk-based thinking. Prepare for and host accreditation and customer assessments.
Safeguard metrological traceability: Ensure an unbroken chain of traceability to national standards (NIST/SI), manage reference standards, and oversee intermediate checks and control charts.
Estimate and defend measurement uncertainty: Develop and review uncertainty budgets (GUM / JCGM 100 methodology, Type A and Type B evaluation), and apply decision rules and statements of conformity per ISO/IEC 17025 and ILAC G8.
Select and validate methods: Establish and validate calibration procedures to meet customer, regulatory, and standard requirements.
Develop the team: Recruit, train, mentor, and assess the competency of calibration technicians; ensure staff correctly interpret procedures, tolerances, and uncertainty.
Be the technical face to customers: Serve as the primary point of contact for technical requests, quotes, and issue resolution; identify opportunities to improve service and grow the business.
Manage standards and budgets: Oversee the inventory, calibration, and recall of reference standards and lab equipment; support capital planning and procurement of new standards.
Drive continuous improvement: Lead initiatives that improve accuracy, efficiency, capacity, and compliance.
Excellent project management skills with the ability to oversee multiple initiatives simultaneously while maintaining attention to detail
Knowledge of laboratory safety protocols and quality assurance practices in regulated environments
Effective communication skills to collaborate across multidisciplinary teams in research & development settings

Calibration Disciplines (experience across several; ability to manage all)

Electrical: multimeters, calibrators, sources, and meters.
Pressure: gauges, transmitters, and dead-weight testers.
Mass / weighing: balances and weights to OIML / ASTM classes.
Temperature: RTDs, thermocouples, baths, and dry-blocks.
Humidity: chambers and hygrometers.
Dimensional: calipers, micrometers, gauge blocks, and comparators.
General instrumentation and related test equipment.

Qualification Requirements:

Bachelor’s degree in Engineering, Physics, Metrology, or a related technical field.
Minimum 10 years of experience in calibration and metrology.
Demonstrated hands-on calibration ability across multiple disciplines listed above.
Strong working knowledge of measurement uncertainty estimation (GUM methodology, Type A/B evaluation) and metrological traceability.
Solid grounding in metrology fundamentals: measurement principles, VIM terminology, statistical analysis, and (for dimensional work) GD&T per ASME Y14.5.
Familiarity with ISO/IEC 17025:2017 and other applicable standards (e.g., ANSI/NCSL Z540.3, ISO 10012, OIML/ASTM mass classes, and customer/regulatory requirements such as cGMP).
Proficiency in Microsoft Excel for building uncertainty budgets, analyzing data, and managing calibration records.
Strong organizational, problem-solving, and communication skills, with the ability to explain complex technical concepts clearly.
Valid driver’s license.
Excellent written and verbal communication skills, with strong attention to detail (Spanish and English)
Experience in an ISO/IEC 17025-accredited laboratory, including supporting or leading accreditation assessments.
Relevant certifications (e.g., ASQ CCT - Certified Calibration Technician, CQE, or NCSLI training).
Experience with calibration management software / LIMS (e.g., IndySoft, GAGEtrak, or similar).
Prior supervisory, training, or team-leadership experience.
Experience supporting regulated industries (pharmaceutical, medical device, aerospace).

Benefits:

Competitive salary based on experience and qualifications.
Job Type: Full-time
Performance bonus.
Professional development - support for training and certifications.
Paid vacation, holidays, and sick time.
Medical, vision, and dental insurance.
401(k) retirement plan.
Full-time

Pay: From $45,000.00 per year

Education:

Bachelor's (Required)

Experience:

calibration and metrology: 10 years (Required)

Work Location: In person

Quick Apply

Refine Your Search

medical device validation jobs in carolina, pr

Calibration & Metrology Laboratory Manager

Validation Quality Engineer

Process Engineer - I

Computer System Validation Engineer - Medical Device Equipment & Regulations

Manufacturing Document Clerk

Manufacturing Engineer I (Entry Level)

Sr. Validation Specialist with Bachelor Degree in Science or Engineering

Commissioning, Qualification & Validation Specialist (CQV)

Validation and CSV Lead Engineer (Validation Lead - Capital Automation Projects)

Environmental Monitoring and Sampling Coordinator Non Standard Shift

Jr. Validation Specialist

Env. Monitoring & Sampling Technician

Jr. Validaiton Specialist - Autoclave

Manufacturing Technician

Process Engineer

Sr. CSV Specialist/ Lab Equipment Qualification

Validation Engineer - Upstream

Mechanic Operator

Validation Engineer

Manufacturing Engineer I (Entry Level- 2nd Shift)

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