Product Quality Engineer

Description

We're looking for a Product Quality Engineer , working in Pharmaceuticals and Medical Products industry in 100 College Street, New Haven, Connecticut, 06510, United States .

Responsibilities:

1. Develops the design control quality plan in line with applicable regulations for combination products including Planning, Design and Development, Verification, Validation and Transfer.
2. Provides Quality oversight of the Design and Development Plan, User Requirement Specifications including Target Product Profile, Risk Management Plan, Design History File, and Design Review.
3. Maintains Product Quality Monographs, Supply Chain Maps, and Device Master Records in compliance with investigational product and commercial marketing applications.
4. Authors Global Annual Product Quality Review, coordinating with leads of contributing chapters.
5. Provides lead quality review of CMC sections of Regulatory submissions and response to queries.
6. Owner of the stability program including ensuring annual commitments are met.
7. Manages reference standard program with a focus on ensuring supply.
8. Facilitates Product Specification Committee.
9. Facilitates global changes with respect to the product and design control.
10. Supports Health Authority inspections and compliance.