Director, Quality Assurance

6 days ago

Austin, Texas, United States Varian Medical Systems Full time
Together, we can beat cancer.


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.

We embrace a culture of inclusivity in which the power and potential of every individual can be unleashed. We spark ideas that lead to positive impact and continued success.

If you want to be part of this important mission, we want to hear from you.

As Director, Quality Assurance you will develop, implement and maintain technical quality assurance and control systems and activities.

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; ensuring employee productivity and growth; managing resources; knowing Varian's business; and maintaining functional, technical, and external market awareness necessary for managing immediate organization.


What You will do:
Develop, review and maintain quality policies in collaboration with corporate quality
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 sterilization validation & biocompatibility compliance testing.
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

What You will have:
Bachelors Degree in engineering, scientific or biomedical discipline. Masters Degree preferred.
10-15 years of medical device experience. Minimum of 7 years management experience.
Ability, competence, and confidence to lead people.
Effective interpersonal skills.
Experience with Class II or Class III medical devices.
Expert working knowledge of FDA 21 CFR Part 820, ISO 13485, and MDR, required.
Corresponding with FDA and EU notified bodies.
Proficient in utilizing business tools such as: E-mail, Microsoft Word, Excel, and PowerPoint.
Experience with HCM (e.g., Workday) or equivalent ERP product and productivity software desired.

# LS-OS1

Fighting cancer calls for big ideas.

We envision a world without fear of cancer. Achieving this vision takes dedication and commitment from all of us, every single day. That's why we celebrate and value the distinctly beautiful and intersectional identities of each of our employees. We are a mirror of our patient-base, which allows us to innovate. 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.

#TogetherWeFight

Privacy Statement

Equal Employment Opportunity Statement

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.

EEO is the Law
Applicants and employees are protected under Federal law from discrimination. To learn more, Click here.

Pay Transparency Non-Discrimination Provision
Varian follows Executive Order 11246, including the Pay Transparency Nondiscrimination Provision. To learn more, Click here.
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