Role: Project Validation Specialist

Location: Anasco, PR

Duration: 12 Months

Job Description:

The position is to support the European Union Medical Device Regulation (EU MDR) program at A asco, PR. The incumbent will be supporting the following activities to ensure conformance with EU MDR for technical filing of products manufactured at A asco, included in the EU MDR program.

Data Gathering Participate in the discovery and compilation of required documentation to be updated as part of the labeling/artwork changes implementation.

Labelling/artwork changes implementation Assess and update all manufacturing documentation such as product device master record (drawings, specifications, bill of materials, production router/instructions, procedures) to implement Labeling/artwork changes. Perform tasks identified as part of the implementation plan including, but not limited to generation and execution of change control, technical reports/memos, First Article Inspections, and manufacturing documentation updates through the site change orders system (Agile).

Requirements:

• 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
• Knowledge of FDA, OSHA, EPA, and GMP's and ISO requirements.
• Proficiency in usage of Minitab and equivalent tools to perform advanced statistical analysis.
• Able to develop technical documentation such as: Change Controls, Validation Plans, Validation Protocols, Technical / investigation reports, SOP, and others.
• Must have excellent communication skills and a strong track record of working cross-functionally.
• Ability to assess technical issues and develop solutions utilizing an analytical approach to problem solving.
• Teamwork oriented and self-starter.
• Fully bilingual (English and Spanish).
• Availability to work extended hours in a day and weekends as required.

Education and/or experience:

• BS in Science or Engineering, preferably Mechanical, Industrial, Electrical, Chemical, or Biomedical.
• Hands-on experience with EU MDR or MDD remediation projects, compliance projects and process validation required.
• Experience with managing documents within electronic PLM system.
• Experience with working with cross functional team.
• Minimum of 5 7 years of experience in the medical device and/or pharmaceutical manufacturing environment; 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