Website:
ivueverse.com
Job details:
Job Summary
We are looking for an experienced Design Controls Consultant to support a project focused on standardizing design control processes across multiple business divisions within a medical device/diagnostics organization. The consultant will assess existing design control documentation, identify gaps, recommend improvements, and help implement standardized SOPs, forms, and templates.
Key Responsibilities
- Review and assess existing Design Control SOPs, forms, templates, and related documentation across multiple divisions.
- Conduct gap assessments to identify differences, inconsistencies, and opportunities for process harmonization.
- Recommend standardized design control processes and documentation aligned with industry best practices.
- Support the development, revision, and implementation of harmonized SOPs, forms, and templates.
- Collaborate with cross-functional teams including R&D, Quality, Regulatory, and Engineering to ensure successful adoption of standardized processes.
- Provide subject matter expertise on Design Controls and Quality Management Systems throughout the project.
Required Qualifications
- Bachelor's degree in Engineering, Life Sciences, or a related discipline.
- Strong experience in Medical Devices or In Vitro Diagnostics (IVD).
- Hands-on experience with Design Controls and Quality Management Systems (QMS).
- Experience conducting process gap assessments and developing or revising SOPs and controlled documentation.
- Strong understanding of applicable medical device quality and regulatory requirements (e.g., FDA Design Controls, ISO 13485).
- Excellent stakeholder management and communication skills.
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