The position involves reviewing and improving design documentation to ensure compliance with current regulatory standards. Responsibilities include conducting gap analyses, drafting remediation plans, organizing electronic records, and supporting knowledge transfer to subject matter experts. The role also requires liaising with various departments to support design control activities, reviewing verification and validation data, and ensuring compliance with relevant regulations.
Key Responsibilities:
- Assess and update existing design documentation to align with regulatory guidelines.
- Develop and implement protocols to address gaps in design documentation.
- Organize and manage electronic records, facilitating knowledge transfer to appropriate experts.
- Support the organization and compliance of design control documentation, adhering to industry regulations.
- Review design control processes, including planning, risk assessment, and documentation.
- Collaborate with other departments to assist in design control review activities.
- Ensure accuracy and completeness of verification and validation data.
- Evaluate and remediate gaps in design history files and other documentation.
- Update legacy product documentation to meet current design control requirements.
- Focus on products with higher risk levels for compliance and documentation updates.
Qualifications:
- Experience with Medical Device Design Controls and Design History Files (DHF).
- Background in quality or engineering roles with experience in quality remediation projects and design controls.
- Engineering degree or equivalent.
- At least 5 years of relevant experience in a regulated industry.
- Familiarity with current Design Control guidelines.
- Strong communication skills and the ability to work effectively with teams and senior leadership.
- Proactive, independent, and a team-oriented approach.
Term & Start:
- Duration: 12+ months
- Hybrid position
