Top 286 Technical product Jobs in Mayagüez, Pr

Project Validation Specialist II - 60622 (Añasco)
One Group —Añasco, PR
- Extended hours
- Background check
- Spanish
- OSHA
Quick Apply
14d
Engineer I, Component Engineering (Hybrid)
Collins Aerospace —Aguadilla, PR
- Full-time
- Hybrid work
- English
- Manufacturing
- 2 years
- Disability insurance
- Health insurance
4d
Onsite IT Technician
CAPITOL BRIDGE PUERTO RICO LLC —Isabela, PR
- $20 an hour
- Monday to Friday
- Microsoft Outlook
- Mid-level
- Office
- Paid training
- Paid holidays
Quick Apply
Advanced Software Engineer - Flight Management System
Honeywell Aerospace —Aguadilla, PR
- Full-time
- Travel
- Senior level
Senior Analyst, Configuration Management Analyst (Hybrid)
Collins Aerospace —Aguadilla, PR
- Full-time
- Hybrid work
- Microsoft Excel
- English
- Office
- Disability insurance
- Health insurance
12d
Senior Systems Engineer, Infrastructure (Hybrid - Aguadilla, PR)
Collins Aerospace —Aguadilla, PR
- Full-time
- Hybrid work
- Azure
- Laboratory experience
- English
- Disability insurance
- Health insurance
Software Engineer II
Honeywell Aerospace —Moca Municipio, PR
- Full-time
- Hybrid work
- Mid-level
- Office
- Travel
Product Engineer – Repair Operations
Hewlett Packard Enterprise —Aguadilla, PR
- Full-time
- Spanish
- DevOps
- English
Project Validation Specialist
Indotronix International Corporation —Añasco, PR
- $35 an hour
- Contract
- Mid-level
Quick Apply
5d
Principal Materials & Process Specialist (Hybrid - Aguadilla, PR)
Collins Aerospace —Aguadilla, PR
- Full-time
- Hybrid work
- 5 years
- English
- Continuous improvement
- Disability insurance
- Health insurance
Data Scientist II- Customer Experience
Honeywell Aerospace —Aguadilla, PR
- Full-time
- Mid-level
- Python
Principal Systems Engineer, Infrastructure (Hybrid - Aguadilla, PR)
Collins Aerospace —Aguadilla, PR
- Full-time
- Hybrid work
- Azure
- Oracle
- 5 years
- Disability insurance
- Health insurance
Field Service Technician
ABB Canada Inc —Aguadilla, PR
- $58,500 - $93,600 a year
- Full-time
- Microsoft Excel
- Customer service
- Military
- Health savings account
- AD&D insurance
Quick Apply
Hardware Engineer II (Hybrid - Aguadilla, PR)
Collins Aerospace —Aguadilla, PR
- Full-time
- Hybrid work
- English
- Mid-level
- Analysis skills
- Disability insurance
- Health insurance
Junior Full Stack Developer & Testing Analyst (JavaScript / AWS)
CIQA Engineering Puerto Rico —Hormigueros, PR
- $13 an hour
- Full-time
- Computer Science
- Office
- SQL
- On-the-job training
- Professional development assistance
Quick Apply
Automation Support Planning Coordinator
Hewlett Packard Enterprise —Aguadilla, PR
- Full-time
- Microsoft Excel
- Writing skills
- English
Plant Manager
Integra LifeSciences —Añasco, PR
- $156,000 - $219,000 a year
- Email
- English
- Master's degree
- Senior level
- Disability insurance
- Health insurance
11d
Design Quality Software/Systems Engineer II (Hybrid - Aguadilla, PR)
Collins Aerospace —Aguadilla, PR
- Full-time
- Hybrid work
- English
- Mid-level
- Continuous improvement
- Disability insurance
- Health insurance
Senior Project Engineer, EPS (Hybrid)
Collins Aerospace —Aguadilla, PR
- Full-time
- English
- Office
- 3 years
- Disability insurance
- Health insurance
Senior Customer Support Mechanical Engineer (Hybrid - Aguadilla, PR)
Collins Aerospace —Aguadilla, PR
- Full-time
- Hybrid work
- Microsoft Excel
- English
- Office
- Disability insurance
- Health insurance

I want to receive the latest job alert for technical product in mayagüez, pr

By signing in to your account, you agree to SimplyHired's Terms of Service and consent to our Cookie and Privacy Policy.

Explore jobs in more locations

technical product jobs near mayagüez, pr

Project Validation Specialist II - 60622 (Añasco)

One Group
Añasco, PR

Quick Apply

Job Details

Full-time | Contract
14 days ago

Qualifications

Spanish
EPA
Teamwork
Content creation for technical audiences
Quality management standards in production
Procedural guides
Bachelor of Science
Engineering
Technical writing experience within manufacturing
Gap analysis
English
Manufacturing standard operating procedures
Bachelor's degree in engineering
Production validation processes
Bachelor's degree
Medical device manufacturing facility experience
Quality control documentation
Pharmaceutical company experience
Compliance documentation
Biomedical regulatory compliance
Cross-functional collaboration
Test validation method
Standard operating procedures (SOPs)
ISO 13485
Cross-functional communication
FDA regulations
Pharmaceutical manufacturing facility experience

Full Job Description

Professional services contract.

Please read all carefully before applying.

Duration: Depends on project's schedule (long term)

Where: Añasco, On-Site

Hour Rate: Depends on the expertise. Negotiable

MINIMUM QUALIFICATIONS

Education and/or experience:

BS in Mechanical Engineering, Industrial Engineering, Chemical Engineering or related science.
Experience in the medical device and/or pharmaceutical manufacturing environment; on a project validation engineer position.
Experience on EUMDR is a must.

Responsibilities:

The position is to support the European Union Medical Device Regulation (EU MDR) program. The incumbent will be supporting the following activities to ensure conformance with EU MDR for technical filing of products manufactured, included in the EU MDR program:
Data Gathering – Participate in the discovery and compilation of required documentation to be evaluated.
Gap Assessments – Assess of all manufacturing documentation such as product device master record (drawings, specifications, bill of materials, production router/instructions, procedures, labeling), process flow charts, incoming inspections, in-process inspections, final inspections, validation plans and process validations, among others.
Remediation Plan – Perform tasks identified as part of the remediation plan including, but not limited to: validation documentation generation and execution (change control, validation plans, validation protocols, validation closure reports, technical reports / memos) and manufacturing documentation update through site change orders system.

The incumbent will be working with cross functional areas on activities described above. Responsible for the delivery of tasks to ensure conformance to the project plan schedule.

Perform assessments and review of all manufacturing and validation documentation associated to product families established by EU MDR program. Provide data to support the gap assessments reports and identify remedial action items based on the outcome of gap assessments. Complete assigned remediation activities to ensure that manufacturing processes and operations are in compliance with requirements of EU MDR. Generate and execute validation protocols, including the coordination of all activities required for protocol completion. Interact and coordinate activities with other departments, external vendors, and customers, as required. Update documentation associated with manufacturing processes which can include drawings, specifications, bill of materials, production router/instructions, procedures, labeling, and process flow charts, among others. Provide training in the updated manufacturing documentation as applicable. Analyze manufacturing process information / data, develop, where necessary, technical justification, rationale and/or other information as required by the company to mitigate risk to acceptable level with adequate documentation. Report project status and progress periodically to site management. Perform other related duties, as required.

Work on official documentation to address technical issues on equipment/processes. Perform Remediation activities as deemed required.

Qualifications:

Knowledge of FDA, OSHA, EPA, and GMP's and ISO requirements.
Must have knowledge of European Union Medical Device Regulation (EU MDR 2017/745), European Union Medical Device Directive 2007/47/EC and ISO13485:2016 Medical Devices – Quality Management Systems.
Must have a thorough understanding of verification and validation processes.
Must have excellent communication skills and a strong track record of working cross-functionally.
Experience with managing documents within electronic PLM system.
Must have demonstrated ability to think strategically.
Must be able to develop technical documentation such as: Change Controls, Validation Plans, Gap Assessments, Validation Protocols (IQ/OQ/PQ), Technical / investigation reports, SOP, and others.
Teamwork oriented and self-starter.

Other Requirements:

Excellent interpersonal and communication skill at all levels.
Fully bilingual (English and Spanish).
Must speak Spanish fluently (native).
Teamwork oriented and self-starter.
Need to have full attention to details.
Skills in working under time pressure.
Availability to work extended hours in a day and weekends if required.
Available to start as soon as possible.
Must live in Puerto Rico. No relocation nor travel expenses available.
Resumes must be in English.
Please, only apply if you are qualified for this position.

Job Types: Full-time, Contract

Application Question(s):

Do you have an engineering or related science bachelor degree?

Education:

Bachelor's (Required)

Experience:

Project Validation Engineer: 3 years (Required)

Language:

Spanish (Required)
English (Required)

Ability to Commute:

Añasco, PR 00610 (Required)

Work Location: In person

Quick Apply

Refine Your Search

technical product jobs in mayagüez, pr

Project Validation Specialist II - 60622 (Añasco)

Engineer I, Component Engineering (Hybrid)

Onsite IT Technician

Advanced Software Engineer - Flight Management System

Senior Analyst, Configuration Management Analyst (Hybrid)

Senior Systems Engineer, Infrastructure (Hybrid - Aguadilla, PR)

Software Engineer II

Product Engineer – Repair Operations

Project Validation Specialist

Principal Materials & Process Specialist (Hybrid - Aguadilla, PR)

Data Scientist II- Customer Experience

Principal Systems Engineer, Infrastructure (Hybrid - Aguadilla, PR)

Field Service Technician

Hardware Engineer II (Hybrid - Aguadilla, PR)

Junior Full Stack Developer & Testing Analyst (JavaScript / AWS)

Automation Support Planning Coordinator

Plant Manager

Design Quality Software/Systems Engineer II (Hybrid - Aguadilla, PR)

Senior Project Engineer, EPS (Hybrid)

Senior Customer Support Mechanical Engineer (Hybrid - Aguadilla, PR)

I want to receive the latest job alert for technical product in mayagüez, pr

Related Searches

Explore jobs in more locations

Job Seeker Tools

Employer Tools

Browse

Stay Connected