The Principal Development Quality Assurance Engineer will provide Quality Engineering expertise to Production, MSTTV, and Development teams for a variety of functions, including design and development projects (internal and external), investigations, and risk identification and mitigation. This role will establish quality system requirements, provide program management for design and development project initiatives, and lead the quality of project documentation to meet all applicable regulations. This role will be responsible for development and maintenance of risk management files.
Essential Duties and Responsibilities
- Provides quality leadership for technology transfer and product development projects, both internally and externally.
- Provides quality leadership for product and system development projects.
- Provides risk management evaluation for development projects and design change assessment.
- Provides expertise to development project managers in identification of risk associated with data and process trending.
- Partners with development personnel in development of tools for process and data monitoring.
- Reviews and approves documents prepared by other team members and development.
- Leads risk mitigation strategies.
- Implements, conducts, and reports on process quality programs using statistical data analysis.
- Generates, prepares, and issues data for assigned quality reports.
- Reporting and presenting to senior staff on process improvements, metrics, audit observations, and analysis.
- Provides leadership for quality engineering initiatives; including policy, processes, and procedure updates and implementation.
- Serves as an expert resource with regards to quality systems and compliance.
- Ability to lead and work effectively with and through multi-functional teams to achieve results.
- Ability to collaborate and work effectively with suppliers with various technologies.
- Excellent interpersonal skills with the ability to collaborate closely with operations staff at varying levels to drive compliance and operational excellence.
- Excellent oral and written communication skills.
- Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.
- Support and comply with the company’s Quality Management System policies and procedures.
- Regular and reliable attendance.
- Ability to work designated schedule.
- Ability to work nights and/or weekends as needed.
- Ability to lift up to 20 pounds for approximately 10% of a typical working day.
- Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 90% of a typical working day.
- Ability to grasp with both hands; pinch with thumb and forefinger; turn with hand/arm; reach above shoulder height.
- Ability to comply with any applicable personal protective equipment requirements.
- Ability and means to travel between Exact Sciences locations (Madison, Redwood City, San Diego, Phoenix, etc.).
- Ability to travel 20% working time away from work location, may include overnight/weekend travel.
- Bachelor’s degree in Engineering, Biology, Chemistry, or related field.
- 8+ years of experience in a product design and development environment.
- 8+ years of experience in risk management.
- 8+ years of experience working within an CFR 820, ISO 13485, ISO 9001, and/or cGMP structured environment.
- Demonstrated ability to perform the Essential Duties of the position with or without accommodation.
- Authorization to work in the United States without sponsorship.
- 5+ years of experience in a biotech product development environment, preferably in a GMP and/or ISO13485 environment.
- 8+ years of experience with Project Management principles and practice.
- 8+ years of experience in product design and development.