Position Details
Project Validation Specialist Iii Apply
Please find the job details and description below and if interested You can reach me at or call me at +1(732)-813-9025.
Role: Project Validation Specialist III
Location: Anasco, PR
Duration: 12 Months
Location: Anasco, PR
Duration: 12 Months
Job Description:
Support the implementation of European Union Medical Device Regulation (EU MDR) compliance for labeling and artwork changes. The role involves updating manufacturing documentation, conducting assessments, and ensuring compliance with regulatory and quality standards.
Support the implementation of European Union Medical Device Regulation (EU MDR) compliance for labeling and artwork changes. The role involves updating manufacturing documentation, conducting assessments, and ensuring compliance with regulatory and quality standards.
Responsibilities:
- Data Gathering: Compile required documentation for labeling and artwork updates.
- Labeling/Artwork Changes: Update product documentation, including device master records, drawings, specifications, procedures, and bills of materials.
- Implementation Tasks: Perform tasks such as change control, technical reports, first article inspections, and document updates in Agile PLM.
- Collaborate with cross-functional teams to meet project plan schedules and ensure compliance.
Required Knowledge, Skills, and Abilities:
- In-depth understanding of EU MDR, MDD, ISO 13485, FDA, OSHA, and GMP requirements.
- Proficiency in statistical analysis tools like Minitab.
- Expertise in developing technical documentation (e.g., change controls, validation protocols, SOPs).
- Strong analytical and problem-solving skills.
- Excellent communication and cross-functional teamwork abilities.
- Fully bilingual in English and Spanish.
- Availability for extended hours and weekends as needed.
Education and Experience:
- Bachelor's degree in Science or Engineering (Mechanical, Industrial, Electrical, Chemical, or Biomedical preferred).
- 5 7 years of experience in medical device or pharmaceutical manufacturing, with a focus on process validation, quality, or manufacturing engineering.
- Hands-on experience with EU MDR/MDD remediation, compliance projects, packaging validations, design control, and product/process transfer.
- Familiarity with electronic PLM systems for document management.
