Job Description

　　Genetic Science Division (GSD) is looking for a strong quality leader to lead the Austin Site Quality organization to achieve Quality objectives and assure compliance with industry standards.

　　The Sr Manager, Quality is a leadership position responsible for implementing and improving Site Quality Management System and Quality Assurance structure to cover various internal functions, build scale, and most importantly, better serve our customers.

　　This position reports directly to the Sr Director of Quality, GSD.

　　Key Duties and Responsibilities

　　Support and provide expertise to the Quality Management System (QMS) and Quality department to successfully meet or exceed goals and targets

　　Collaborate with the various functions to ensure the quality management system is comprehensive, incorporates standard processes, and is consistent with the strategic plan

　　Product Development responsibilities including design controls, risk management, document control and record management, and supplier management

　　Manufacturing responsibilities including master record, training, process controls, labeling, change control, and CAPA

　　Responsible for monitoring and measurement including validations, calibrations, customer feedback and complaints, internal audits

　　Responsible for all site quality metrics and reporting for monthly and quarterly business reviews - e.g., Product Complaint rates, Cost of Poor Quality, CAPA, etc.

　　Support and provide quality expertise to the business process transfer activities - e.g., process implementation/validation

　　Hire and retain a diverse, highly qualified staff and provides ongoing performance feedback. Set goals which align to department plans and lead the execution of goals through coaching and mentoring

　　Ensure continuous improvement through the Practical Process Improvement (PPI)

　　Install and maintain a quality culture - Right First Time

　　Minimum Requirements/Qualifications:

　　Bachelor of Science Degree in - Life Sciences, Engineering or related science/engineering degree preferred

　　10+ years of professional quality experience - quality leadership experience preferred

　　Understanding of the Life Sciences and IVD/Medical Devices industries and required compliance regulations for Genetic Sciences products and processes

　　Solid understanding and experience with ISO 9001 and ISO 13485 standards

　　Experience in MDSAP, IVD/IVDR, 510K and GxP requirements preferred

　　Ability to travel domestically and internationally - up to 15%

　　Expert knowledge and experience implementing the following:

　　Design and Process FMEA's (Failure Mode Effects Analysis)CAPA (Corrective and Preventive Actions) processNPI (New Product Introduction) process - Design Transfer, V&VComplaints Handling processChange Control process

　　Desired Qualifications:

　　Contributes as a valued team member and colleague with leaders at all levels

　　Experience working and providing customer support, investigations, and relationship management

　　Validated communication and customer management skills

　　Experience supporting change management efforts

　　Validated people leadership skills

　　Demonstrates personal awareness and desire for continual learning and personal development

　　Hands-on and action oriented - Normally receives little instruction on day-to-day work, general instructions on new assignments

　　Must possess the presentation skills and integrity to project a professional image, both internally and externally

　　Strong interpersonal, verbal and written communications skills are crucial