Director-Policy Management - Austin, TX, United States - BuildSubmarines
Description
At Varian, a Siemens Healthineers Company, we bring together the world's best talent to realize our vision of a world without fear of cancer.
Together, we work passionately to develop and deliver easy-to-use, efficient oncology solutions.
We are part of an incredible community of scientists, clinicians, developers, researchers, professionals, and skilled specialists pushing the boundaries of what's possible, to improve people's lives around the world.
Your scope will define and specify the implementation of standards, methods and procedures for inspecting, testing and evaluating the precision, accuracy and reliability of company products.
You will participate in the reviewing of engineering designs to contribute quality requirements and considerations, assist product support areas in gathering and analyzing data, and select, develop, evaluate personnel to ensure the efficient operation of the function.
You will perform all required management responsibilities including but not limited to: implementing the company's policies, programs, and guidelines; managing resources; and maintaining functional, technical, and external market awareness necessary for managing immediate organization.
Keep the site and corporate leadership teams informed about quality-related problems and issues
Assure regulatory compliance with pertinent outside agencies
Oversee and manage the overall quality organization, including design assurance, manufacturing quality, and audit compliance.
Manage all aspects of the Quality Management System (QMS), including the Quality Manual and procedures/processes, such as document and data control, quality planning, training, vendor approval/monitoring, equipment maintenance and calibration, complaint handling and trending, product recalls/advisory notices, corrective and preventive action system, non-conforming materials, and incoming and final inspection.
Manage design control activities for new and sustaining product development efforts, including risk analysis activities, such as design and process FMEA, design and process (IQ/OQ/PQ) validation/verification activities, and software validation.
Oversee monitoring and maintenance of clean room environments, including certification and maintenance to international standards.Conduct internal and external audits of the Quality System.
Represent the QMS internally (Authorized Management Representative) and to external customers.
Report on the performance of the quality management system to senior management
Bachelors Degree in engineering, scientific or biomedical discipline years of medical device experience. Minimum of 7 years management experience.
Experience with Class II or Class III medical devices.
Proficient in utilizing business tools such as: E-mail, Microsoft Word, Excel, and PowerPoint.
Workday) or equivalent ERP product and productivity software desired.
# Big ideas come from everywhere, and the best ideas are fostered by our unique individual experiences. At Varian, we encourage you to bring your whole self to work and believe your bold and authentic perspective will help to power more victories over cancer.
#Varian is an Equal Opportunity and Affirmative Action Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability unrelated to ability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, order of protection status, protected veteran or military status, or an unfavorable discharge from military service, and other categories protected by federal, state or local law.
Varian follows Executive Order 11246, including the Pay Transparency Nondiscrimination Provision.