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.
Open to Remote Canada or US
Quality Systems and Regulatory Specialist is a member of the Design Quality and Compliance team responsible for working with design teams to review for compliance of design control documentation, to perform cause investigations and help implement and verify corrective actions, and drive improvements in processes for standalone software products / Software as a Medical Device (SaMD).
Responsibilities:
Participate as an independent compliance specialist to review and approve design control documentation on cross-functional design and development teams, including software design and development plans, verification, validation, usability planning/testing, risk management, cybersecurity, and other project deliverables:
Review deliverables and collaborate with teams as required to ensure compliance of design inputs and design outputs
Participate in Discrepancy Report Review Board to ensure that product defects are reviewed and handled in a prompt, consistent and compliant manner
Liaise between departments, teams, managers and suppliers to ensure requirements are met
Support supplier qualification activities for third party software components or services
Review/Audit Design History Files for conformance to requirements
Work with process owners to identify the need for corrective or preventive action and create, implement and/or audit effectiveness of CAPA plans:
Identify and report nonconformances/deficiencies in the product and/or quality system
Perform cause investigations with the teams to determine cause of product and/or quality system issues
Review and follow-up on design control process-related audit non-conformances, CAPAs and customer complaints/field problems, to establish a closed-loop system
Work with cross functional team to update or implement updates in processes, procedures, instructions and templates related to design controls
Perform effectiveness checks to ensure effectiveness of corrective/preventive actions
Perform and/or support compliance audits:
Perform or support internal quality audits to verify conformance to quality system and other requirements, as required/assigned
Support third party compliance audits
Requirements:
At least 3 years of experience in a Quality Assurance or regulatory function and/or post-secondary degree in a relevant field (such as Engineering, Computer Science or Sciences)
Excellent technical writing and oral communication skills
Excellent organizational, problem-solving, and analytical skills
Experience working in a cross-functional team environment
Ability to influence and interact with cross-functional team members
Ability to plan, organize, and implement concurrent tasks and projects
Ability to manage priorities in a fast-paced environment
Proficiency utilizing business tools such as e-mail, Microsoft Word, Excel, and PowerPoint, and other productivity software
The following experience or knowledge would be considered an asset and/or the applicant should be prepared to acquire on-the-job training in the following:
Knowledge of software development, agile, cloud infrastructure
Experience in a regulated industry and/or medical device industry
Implementing and/or auditing to standards or regulations such as ISO 13485, ISO 14971, IEC 62304, FDA QSR, EU MDR, MDSAP
Participation in or support of ISO or regulatory audits
ISO 13485 (Lead) Auditor certification, ASQ CQE, CQA and/or CSQE certification
Experience in performing risk management activities
Experience in or knowledge of cybersecurity standards and requirements
Experience performing supplier qualification activities
#LI-CORP1
To ensure compliance with applicable legal requirements in the U.S., including the federal COVID-19 vaccination mandate, all U.S. employees must be fully vaccinated for COVID-19, subject to legally required and approved accommodations.
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 (https://www.varian.com/sites/default/files/Job%20Applicant%20Privacy%20Notice%203%2027_final.pdf)
The base pay range for this position in Colorado is
Min $70,500 – Max $123,500
Together, we can beat cancer.
Imagine a world without fear of cancer. We do, every day. Varian Medical Systems, a Siemens Healthineers Company, is the world’s leading manufacturer of medical devices and software for treating and managing cancer. For more than 70 years, we have developed, built, and delivered innovative cancer care technologies and solutions for our clinical partners around the globe to help them treat millions of patients each year.
Varian & Siemens Healthineers have united to accelerate our path to further innovation. Taking an Intelligent Cancer Care approach, we are harnessing advanced technologies like artificial intelligence, machine learning, and data analytics to advance cancer treatment and expand access to care to help patients become survivors.
When you join Varian, combined with Siemens Healthineers, you become part of a global network of innovative and inspired minds working together across the globe. We keep the patient and our clinical partners at the center of our thinking as we power new victories in cancer care. Because for cancer patients everywhere, their fight is our fight.
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