Product Quality Engineer

3 weeks ago


New Haven, United States CareerBuilder Full time

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:
Develops the design control quality plan in line with applicable regulations for combination products including Planning, Design and Development, Verification, Validation and Transfer
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
Maintains Product Quality Monographs, Supply Chain Maps, and Device Master Records in compliance with investigational product and commercial marketing applications
Authors Global Annual Product Quality Review, coordinating with leads of contributing chapters
Provides lead quality review of CMC sections of Regulatory submissions and response to queries
Owner of the stability program including ensuring annual commitments are met
Manages reference standard program with a focus on ensuring supply
Facilitates Product Specification Committee
Facilitates global changes with respect to the product and design control
Supports Health Authority inspections and compliance

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