Location: Añasco, PR

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) 

 
 
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.