Manager, Quality Engineering


Job ID 19-00080

Industry Pharma

Job Type Permanent

Location Edison, NJ

Description

Overview:
To manage Company's quality engineering group and ensure the validation program is in compliance with applicable government regulations and industry standards including the U.S. Food and Drug Administration, and the standards of the American Association of Tissue Banks.

Responsibilities:
1. Manages the activities of Quality Engineering staff at multiple Company facilities.
2. Oversees the design, coordination, performance, analysis, reporting, and maintenance of process validations and equipment qualifications to comply with cGMP, QSR, GTP, and AATB Standards and other applicable standards. Updates senior management on critical issues related to these activities.
3. Communicates with Quality Assurance, Research & Development, and other departments with product development studies, validation and other engineering projects.
4. Designates Quality Engineering staff and resources to interdepartmental teams and projects.
5. Oversees the coordination special project testing with outside consultants as needed.
6. Oversees the identification and development of production controls for new or existing products and processes.
7. Supports the regulatory submission process for tissue-based products and medical devices.
8. Represents Company on matters of quality engineering with QA personnel, other departments and suppliers of goods and services used in tissue processing and distribution.
9. Assists on special projects and performs additional duties as assigned. (exempt)



Qualifications

Qualifications:
1. Bachelor's degree in engineering required. CQE certification helpful.
2. Minimum 3 to 5 years of quality engineering or validation experience in an FDA regulated field.
3. Minimum of 3 to 5 years management experience desired.
4. Experience in project management, design control, and risk management desired.
5. Excellent communication, organizational, and technical writing skills.