Serve as the Quality representative on cross-functional project teams for new product introduction (NPI), product updates, and manufacturing transfers.

Ensure compliance with applicable standards and regulations (e.g., ISO 13485, FDA 21 CFR Part 820, MDR) throughout the product lifecycle.

Lead and support verification & validation (V&V), risk management (ISO 14971), and product transfers as per Customer requirements and FMCR Quality Management System.

Review and approve document change orders (DCRs), device master records (DMRs), technical documentation and validation protocols and reports.

Collaborate with Customers, Manufacturing, Engineering and Supply Chain to drive quality in all phases of development.

Participate in risk assessments (FMEAs) and ensure risk controls are implemented and verified.