Director, Quality Assurance
Company: Varian Medical Systems, Inc.
Location: Austin
Posted on: May 2, 2024
Job Description:
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 managementWhat 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-OS1Fighting 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.#TogetherWeFightEqual Employment Opportunity StatementVarian
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 LawApplicants and employees
are protected under Federal law from discrimination. To learn more,
.Pay Transparency Non-Discrimination ProvisionVarian follows
Executive Order 11246, including the Pay Transparency
Nondiscrimination Provision. To learn more,.
Keywords: Varian Medical Systems, Inc., Austin , Director, Quality Assurance, Executive , Austin, Texas
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