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-fu...