Medical Device Validation Expert

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 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...

Labchems Corp. seeks a highly skilled Validation Specialist to join our team in supporting the EU MDR program. As a key member of our team, you will be responsible for ensuring compliance with EU MDR regulations by conducting thorough gap assessments and developing comprehensive remediation plans. Your expertise in validation activities, project management,...

About Flexible & Integrated Technical Services, LlcWe are a Service Provider company dedicated to delivering top-notch quality talent to the Pharmaceutical, Medical Device and Manufacturing industry.

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...

Key Responsibilities:Support the design changes impacting operations, manufacturing, launch readiness and production stability requirements of existing productsProvide technical expertise and project leadership in areas such as medical device life cycle management, supplier change management, COGs, process development, validation and production...

At Labchems Corp., we are seeking a highly skilled Project Validation Specialist to support the efficient and timely completion of projects related to sterilization areas. This includes new Ethylene oxide sterilization cycle validation, existing Ethylene oxide sterilization cycle re-validation, and sterilization cycle improvements.This role requires a...

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...

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...

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...

The role of this position is to provide support to the European Union Medical Device Regulation (EU MDR) program at Labchems Corp. The successful candidate will be responsible for participating in data gathering and compilation of required documentation, conducting gap assessments on manufacturing documentation, and performing remediation tasks.Key...

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...

Labchems Corp. is committed to excellence in laboratory services, including sterilization validation and improvement. We are currently seeking a Validation and Sterilization Lead to oversee and manage various projects related to sterilization areas.This critical role involves leading cross-functional teams, developing and implementing validation plans,...

The Manufacturing Engineer II, Life Cycle Management (LCM) will work within Engineering group to support the design changes impacting operations, manufacturing, launch readiness and production stability requirements of existing products. Will also provide technical expertise and project leadership in the areas of medical device life cycle management,...

Labchems Corp. is looking for a Sterilization Process Expert to join our team. As a key member of our sterilization workstream, you will be responsible for ensuring the efficient and timely completion of project-related tasks.Key responsibilities include interpreting microbiological testing data, monitoring and maintaining sterility assurance, and conducting...

Laboratory scientists and professionals at Labchems Corp. aim to ensure the highest quality and safety standards in sterilization processes. To achieve this goal, we need a Senior Sterilization Expert who can lead and guide our team members in their roles.The ideal candidate will have extensive knowledge of microbiology and sterilization techniques,...

About the Role:As a Manufacturing Engineer II, Life Cycle Management (LCM), you will work closely with the Engineering group to ensure that design changes do not negatively impact operational efficiency, manufacturing processes, or production stability.Responsibilities include providing technical expertise and project leadership in areas such as medical...

Job Description:The Manufacturing Engineer II, Life Cycle Management (LCM) will support the design changes impacting operations, manufacturing, launch readiness and production stability requirements of existing products within Labchems Corp.'s Engineering group.This role will provide technical expertise and project leadership in areas such as medical device...

Job Description:Labchems Corp. is seeking a highly skilled Production Process Specialist - Life Cycle Management to join our Engineering team.About the Role:This position will work closely with cross-functional teams to support design changes impacting operations, manufacturing, launch readiness, and production stability requirements of existing products.The...