Configuration and Design Change Control for R&D department

Job Requirements

Education:

• Associate's or Bachelor's degree in Engineering, Quality, or a related field (or equivalent experience).

Key Responsibilities:

• Coordinating and processing ECRs from initiation to completion.
• Ensuring timely review and approval of change requests by relevant stakeholders.
• Updating and maintaining risk management files and other related documentation.
• Participating in configuration audits to verify compliance with policies and standards.
• Maintaining comprehensive documentation, configuration management systems, and updated JIRA tickets.
• Ensuring that documentation is well-organized, and consistently up to date.

Technical and Soft Skills:

• Strong technical understanding to comprehend changes initiated by the system engineering, software, and mechanical teams.
• Excellent communication and collaboration skills for interacting with cross-functional teams.
• Exceptional organizational skills: Ability to efficiently manage multiple ECRs and tasks simultaneously while ensuring accuracy and adherence to timelines.
• Detail-oriented approach to ensure accuracy and compliance with documentation standards and regulatory requirements.

Advantages:

• Experience in managing ECRs or working within an engineering or R&D environment, preferably in the medical device industry.
• Familiarity with configuration management or document control processes.
• Background in quality assurance or quality management systems (e.g., ISO 13485).
• Knowledge of risk management practices.
• Familiarity with medical device regulatory requirements (FDA, IVDR).