HARD SKILLS

• Quality System Regulations and ISO 13485 requirements.
  o Good Documentation Practice (GDP)
  § ISO 13485 clause:

4 Quality Management System|4.2 Documentation Requirements|4.2.5 Control of Records

• Change control and evaluate impact on manufacturing, duplicated production lines, and equipment shared with other BUs
• MS Office applications (word and excel) and Windows operating system.

o Able to “redline” (track changes) in MS word

• Excellent computer skills
• Proficiency in using databases for document control and change management systems: Agile; SAP; Polarion; Neptune
• Experience in automated change control system (ACCS) or document control system (i.e. Agile preferably)
• Technical writing
• Preferable experience in medical device or other regulated industry

SOFT SKILLS:

• Cross-functional teamwork
• Well-developed written and verbal communication skills
• Ability to handle multiple projects and priorities in a fast-paced environment.
• Strong attention to detail
• Ability to organize and track multiple items of a project simultaneously.
• Efficient
  Prepare ECOs and associated documentation for review and release in Agile (ACCS)
  Ensure all documents comply with organizational standards and regulatory requirements.
  Develop and enforce document control procedures and best practices across teams.
  Regularly audit documentation to ensure accuracy and completeness

REQUIRED SKILLS AND EXPERIENCE

Strong understanding of change management methodologies and best practices
1-3 year experience in Document, Data, and Record Control Management function
Must have excellent computer skills and be proficient in relevant software tools for document control and change management systems - Agile; SAP; Polarion; Neptune
Ability to handle multiple projects and priorities in a fast-paced environment.
Strong attention to detail and ability to track various components of a project simultaneously.
Required Education and Training

Please refer the Job description for details