The QA Manager will oversee the supplier management program and will be a key participant on product development and process improvement teams by leading the risk management product/process activities and software quality validation activities. The position also provides guidance on quality issues including validation planning, design controls and procedural recommendations for corporate standard operating procedures.
• Provides validation support of Vaisala temperature monitoring system and other facility systems for new equipment. Provides validation oversight of the calibration system module in MasterControl. (~40%)
• Provides software quality validation support for software applications systems. (20%)
• Oversees/monitors the supplier management program. Develops, maintains and evaluates the effectiveness and quality capability of suppliers. Conducts supplier audits. (10%)
• Oversees the management of the electronic Document Management function. Implements quality system modules such as deviations, internal audits and nonconforming materials in the electronic Document system as needed. (15%)
• Responsible for quality assurance activities for new product development including risk management activities. (10%)
• Participates as liaison to all laboratory locations regarding the Quality Management System. (5%)
Frequently interacts with subordinates, peers and various management levels across departments to ensure quality compliance. Interaction normally requires the ability to gain cooperation of others, conducting presentations of technical information concerning specific projects / schedules.
• Internal Customers - Directly interacting, by such activities as internal audits and complaint investigations.
• External Customers - Acts as liaison with external parties on matters relating to Sequenom’s quality system.
• Manufacturing – Oversees the development of inspection control plans, and directing the quality system controls to support manufacturing operations.
• Engineering - Supports equipment design and validation efforts, and directing quality department support activities for product, component, processes and software validation/qualification.
• R&D – Collaborates on the implementation of Design Controls procedure. Ensures quality control resources and support for product development and product improvement projects.
• Materials – Oversees supplier quality management audit program.