Validation Specialist for Medical Devices

Job OverviewLabchems Corp. is seeking a highly skilled Medical Device Validation Engineer to support the European Union Medical Device Regulation (EU MDR) program.About the RoleThe successful candidate will participate in data gathering, gap assessments, remediation planning, and documentation generation and execution for EU MDR compliance.Key...

Support the European Union Medical Device Regulation (EU MDR) program with the following activities: 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...

**Job Summary**We are seeking a highly skilled Quality Control Engineer - Medical Devices to join our team! As a key member of our Quality Engineering team, you will be responsible for investigating manufacturing product quality and compliance issues, analyzing results, making recommendations, and developing reports. You will also optimize manufacturing...

Job RequirementsWe are seeking an experienced Quality Assurance and Validation Lead to join our team. The successful candidate will be responsible for ensuring the quality and integrity of our products and processes.About the RoleThe Quality Assurance and Validation Lead will be responsible for:Supporting the development and implementation of quality and...

As a Validation & Quality Engineer at Flexible & Integrated Technical Services, LLC, you will be an integral part of our team, contributing to the success of our clients in the Pharmaceutical, Medical Device, and Manufacturing industries. Key responsibilities include:Developing SOPs and ensuring compliance with regulatory guidelinesSupporting the execution...

At Labchems Corp., we are seeking a Senior Validation Specialist to support the efficient completion of project-related tasks for the sterilization area. This includes new Ethylene oxide sterilization cycle validation, existing Ethylene oxide sterilization cycle re-validation, and sterilization cycle improvements.The ideal candidate will have advanced...

We are a Service Provider company different from the rest. Flexible & Integrated Technical Services, Llc prides ourselves in how we treat the most important piece of our company's puzzle: you**Job Summary:**This role will be responsible for ensuring timely and thorough execution of Computer System Validation protocols, meeting FDA requirements. You will...

Company OverviewLabchems Corp. is a leading manufacturer of high-quality laboratory chemicals and equipment. Our commitment to innovation and customer satisfaction has earned us a reputation as a trusted partner in the scientific community.Job DescriptionWe are seeking a highly skilled EU MDR Compliance Specialist III to join our team. The successful...

Support CORPORATE STERILIZATION WORKSTREAM for efficient and timely completion of project related to sterilization area including, new Ethylene oxide sterilization cycle validation, existing Ethylene oxide sterilization cycle re-validation, and sterilization cycle improvements, among others. Interprets microbiological testing data, monitors, and maintains...

The position is to support the European Union Medical Device Regulation (EU MDR) program. The incumbent will be supporting the following activities: -- 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...

For Validation services in the Engineering & Manufacturing areas.  WHAT MAKES YOU A FIT:  The Technical Part: Bachelor's Degree in Engineering and previous exposure to validation quality activities within the Pharmaceutical or Medical Devices industry.  Bilingual, Spanish and English (good communication) Shift: Administrative & according to business...

About Our CompanyFITS is a unique service provider company that integrates Engineering, Construction, Maintenance, Utilities, and Specialized Technical services across the Island and in the US. We value our resources' well-being and provide top-notch quality talent to our Pharmaceutical, Medical Device, and Manufacturing industry clients.Job OpportunityWe...

We are Flexible & Integrated Technical Services, LLC, a service provider company offering Engineering, Construction, Maintenance, Utilities, and Specialized Technical services across the island and in the US. As a Validation & Quality Engineer, you will play a crucial role in our team by supporting engineering department operations, managing quality systems,...

For Validation & Quality services in the Engineering & Manufacturing areas.  WHAT MAKES YOU A FIT:  The Technical Part: Bachelor's Degree in Engineering and previous exposure to validation and/or quality activities within the Pharmaceutical or Medical Devices industry.  Bilingual, Spanish and English (good communication) Shift: Administrative & according...

The position is to support the implementation of labeling / artwork changes on Duragen product family for CE and non-CE marked SKUs. The incumbent will be supporting the following activities to ensure conformance with global labeling SOP for Duragen products manufactured at Integra Añasco.• Data Gathering – Participate in the discovery and compilation...

Job DescriptionWrite, execute and maintain validation protocols on a timely basis.Ensure thorough and complete execution of all protocols, meeting FDA requirements.Develop documentation of investigations and communicate findings to minimize chance of recurrence.This role requires strong technical skills in SOP development, validation documentation, GMP and...

For Validation Engineering services in the Facilities area.WHAT MAKES YOU A FIT:  The Technical Part: Bachelor's Degree in Engineering or related field and at least three (3) years of previous exposure to Validation  activities within the regulated industry.Bilingual: (Spanish and English) Shift: Administrative & according to business needs  Experience...

We are seeking a highly experienced EU MDR Compliance Specialist to join our team at Labchems Corp. As a critical member of our compliance team, you will be responsible for ensuring that our company remains compliant with EU MDR regulations. Your expertise in validation activities, project management, and technical documentation will be essential in...

Flexible & Integrated Technical Services, LLC offers a dynamic work environment that values innovation and customer service. As a member of our team, you will be responsible for supporting engineering department operations, managing quality systems, and ensuring compliance with regulatory guidelines.Responsibilities include:Creating and revising protocols...

**About Us**Flexible & Integrated Technical Services, LLC is a unique service provider that integrates engineering, construction, maintenance, utilities, and specialized technical services across the island and in the US. We pride ourselves on treating our resources like family while delivering top-notch quality talent to clients in the Pharmaceutical,...