Boston Scientific R&D Documentation Specialist 

Canada, Quebec, Montreal 

710067218

Your responsibilities will include:

• Create, coordinate, and maintain all controlled document files using an electronic system.
• Copy, distribute and maintain documents in accordance with company procedures.
• Review final version of documentation changes for any potential issues and work with engineers to resolve them.
• Develop, receive, and review process engineering changes notices (CNs) and design change assessments (DCAs).
• Change Notice (CN) Process: Process CN through various stages of the CN process. This may include CN creation, Submission Review; Implementation, and Document Issuance (Manages the distribution of documents as needed).
• Interpret and implement corporate documentation requirements as they relate to local documentation requirements.
• Coordinate Change Control Board Documentation requests:
  • Ensure engineering documentation is changed in a timely and accurate manner.
  • Ensure new part numbers are created utilizing established naming conventions, product structures are developed, and parts being changed are clearly flagged to support engineering changes and new product releases.
  • Review CN packages for completeness and accuracy.
  • Ensure CNs are prepared and distributed to functional areas as defined by the CN process.
• Inform the appropriate individuals when CNs are approved to facilitate a smooth change or introduction.
• Aid in training personnel regarding document format, content, use, control, and the document control system.

Required qualifications:

• Bachelor’s degree or equivalent in a related field.
• 3-5 years related experience in the medical device industry.
• 2+ years’ experience managing documentation and complex activities.
• Experience managing multiple electronic documentation systems and processing documents and drawings for approval.
• A knowledge and understanding how regularly available information is developed and maintained including drawings, design specifications, AML/AVLs and internal bills of material (BOMs).
• Experience managing electronic documentation systems and processing documents and drawings for approval.
• Excellent organizational, communication and collaboration skills.
• Excellent documentation skills.

Preferred qualifications:

• Experience using electronic document systems such as Windchill.
• Ability to work under limited supervision and manage multiple tasks and prioritize assignments with limited time constraints while working consistently in a fast-paced environment.
• Flexibility and ability to adjust to changing priorities and unforeseen events.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.