Job Description:
The position is to support the European Union Medical Device Regulation (EU MDR) program at Integra A asco, PR. The incumbent will be supporting the following activities to ensure conformance with EU MDR for technical filing of products manufactured at Integra 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 / artworks changes implementation.
Labeling / artworks 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 / artworks 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 update through site change orders system (Agile).

The incumbent will be working with cross functional areas on activities described above. Responsible for the delivery of tasks to ensure conformance to the project plan schedule.

Knowledge, skills, and abilities:
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