Summary: The position is to support the European Union Medical Device Regulation (EU MDR) program at Añasco, PR.
Responsibilities:
The incumbent will be supporting the following activities to ensure conformance with EU MDR for technical filing of products manufactured at Añasco, 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.
Requirements:
Bachelor’s degree in Engineering, Microbiology or similar discipline.
Minimum of 7 years of experience in the medical device and/or pharmaceutical manufacturing environment with effective experience and knowledge in sterilization processes.
Demonstrates excellent organizational and communication skills.
Results oriented with a strong focus on quality principles.
Excellent technical writing skills with an understanding of good documentation practice. Able to develop technical documentation such as: Change Controls, Validation Plans, Validation Protocols, Technical / investigation reports, SOP, and others.
Working knowledge of applicable regulations and their interpretation within industry.
Knowledge in Project Management skills and Microsoft Project software.
Ability to track milestones and manage projects.
Fully bilingual (English and Spanish)
Applicant Notices & Disclaimers
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At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 34.05/hr.
