
Medical Device Validation Engineer
hace 1 día
Job Overview
Labchems Corp. is seeking a highly skilled Medical Device Validation Engineer to support the European Union Medical Device Regulation (EU MDR) program.
About the Role
The successful candidate will participate in data gathering, gap assessments, remediation planning, and documentation generation and execution for EU MDR compliance.
Key Responsibilities
- Data Gathering–Participate in the discovery and compilation of required documentation to be evaluated.
- Gap Assessments–Assess all manufacturing documentation such as product device master record, process flow charts, incoming inspections, final inspections, validation plans and process validations.
- Remediation Plan–Generate and execute validation documentation (change control, validation plans, validation protocols, validation closure reports, technical reports / memos) and update manufacturing documentation.
Requirements
• BS in Science or Engineering (Mech, Ind, Elec, Chem, or Biomedical)
• 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.
• Hands-on experience with EU MDR or MDD remediation projects, compliance projects and process validation are required.
• Minimum of 5 – 7 years of experience in the medical device and/or pharmaceutical manufacturing; with at least five (5) years in manufacturing process, quality or validation engineering position and preferably with exposure to Packaging Validations, Design Control and Product/Process Transfer.
• Proficient with Minitab for advanced statistical analysis.
• Able to develop technical documentation such as: Change Controls, Validation Plans, Validation Protocols, Technical / investigation reports, SOP, and others.
-
Project Validation Specialist Iii
hace 1 día
Añasco, Puerto Rico Labchems Corp. A tiempo completoSupport 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...
-
Validation and Compliance Professional
hace 5 días
Añasco, Puerto Rico Flexible & Integrated Technical Services, Llc A tiempo completoAs 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...
-
Quality Assurance and Validation Lead
hace 21 horas
Añasco, Puerto Rico Labchems Corp. A tiempo completoJob 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...
-
Validation & Quality Engineer
hace 5 días
Añasco, Puerto Rico Flexible & Integrated Technical Services, Llc A tiempo completoFor 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...
-
Process Validation Engineer
hace 2 semanas
Añasco, Puerto Rico Flexible & Integrated Technical Services, Llc A tiempo completoFor 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...
-
Validation Specialist for Medical Devices
hace 1 día
Añasco, Puerto Rico Labchems Corp. A tiempo completoLabchems 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,...
-
Facilities Validation Engineer
hace 3 semanas
Añasco, Puerto Rico Flexible & Integrated Technical Services, Llc A tiempo completoFor 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...
-
Project Validation Specialist Eu Mdr
hace 3 semanas
Añasco, Puerto Rico Labchems Corp. A tiempo completoThe 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...
-
Senior Validation Engineer
hace 24 horas
Añasco, Puerto Rico Labchems Corp. A tiempo completo**About Us:**Labchems Corp. is a leading organization in the industry, committed to delivering high-quality products and services.We are seeking a skilled Senior Validation Engineer to join our team and contribute to our mission.This role involves supporting facilities and construction projects, mainly in Collagen areas, by participating in meetings and...
-
Manufacturing Engineer
hace 4 semanas
Añasco, Puerto Rico Eqval A tiempo completoEQVAL Consulting Group, Inc. is a company that provides services to the manufacturing industry ( Medical Devices, Pharmaceuticals, Biotechnologies, others ).We work with an extraordinary group of professionals ( employees and contractors ) to accomplish the requirements established by our customers, in order to perform and provide a highly effective...
-
Process Engineer
hace 3 semanas
Añasco, Puerto Rico Flexible & Integrated Technical Services, Llc A tiempo completoFor Validation services in the Facilities area.WHAT MAKES YOU A FIT: The Technical Part: Bachelor's degree in Engineering and a minimum of five (5) years of exposure in Validation activities within the Pharmaceutical or Medical Device Industry.Excellent verbal/written communication skills (English and Spanish) Shift: Administrative & according to...
-
Quality Engineer
hace 3 semanas
Añasco, Puerto Rico Kelly Science, Engineering, Technology & Telecom A tiempo completoQuality Engineer (QE) resource will be allocated to work with the facilities/construction projects, mainly in Collagen Manufacturing areas. The QE resource is required to be part of the Core Team of the facilities projects, participate on meetings and to review and approve all documentation required such as PCDT, Change Control, EMPQ, equipment...
-
Quality Control Engineer
hace 5 días
Añasco, Puerto Rico Flexible & Integrated Technical Services, Llc A tiempo completo**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...
-
Technical Services Specialist
hace 5 días
Añasco, Puerto Rico Flexible & Integrated Technical Services, Llc A tiempo completoWe 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,...
-
Process Validation Expert
hace 7 horas
Añasco, Puerto Rico Flexible & Integrated Technical Services, Llc A tiempo completoAbout 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.
-
Project Validation Specialist
hace 4 semanas
Añasco, Puerto Rico Kelly Science, Engineering, Technology & Telecom A tiempo completoThe 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...
-
Process Improvement Engineer
hace 3 días
Añasco, Puerto Rico Labchems Corp. A tiempo completoProcess Improvement Engineer Job Description">Labchems Corp. is seeking a Process Improvement Engineer to drive quality excellence in our facilities and construction projects. As a key member of the Core Team, you will develop and implement quality programs, analyze data, and identify areas for improvement. Your primary responsibilities include developing...
-
EU MDR Compliance Specialist III
hace 1 día
Añasco, Puerto Rico Labchems Corp. A tiempo completoCompany 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...
-
Regulated Manufacturing Project Coordinator
hace 1 día
Añasco, Puerto Rico Labchems Corp. A tiempo completoThe 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...
-
Project Validation Spec.
hace 1 día
Añasco, Puerto Rico Labchems Corp. A tiempo completoSupport 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...