Varian Medical Systems Regulatory Affairs Engineer - Healthcare Software in Pune, India
Together, we can beat cancer.
At Varian, 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. If you want to be part of this important mission, we want to hear from you.
We are hiring RA/QA Engineer who will be responsible for minimizing risk to the organization associated with product design and realization efforts and assists in ensuring robust medical device product designs under governing domestic and international requirements.
Provides support and typically works as a member of one or more new product development and/or sustaining engineering projects. Typically serves as the quality representative on the project team and works closely with the project team leader.
Major on-going responsibilities for, but not limited to:
Is a member of Pune engineering team and has the responsibility and authority for ensuring Quality System requirements are established and maintained in accordance with applicable quality procedures of Varian Product Life Cycle (PLC)
Participate in reviews of designs and design documentation to ensure that all domestic, international engineering practices, Quality System documentation, laws and regulations are being met consistently.
Support Quality group during internal/external audits with respect to internal Quality System documentation and all appropriate regulations.
Review ECN’s to ensure compliance to Quality System, QSR and International standards and requirements for Product Life Cycle (PLC) and sustaining activities.
Ensure that product development projects and changes to existing products are conducted in compliance with all appropriate regulations and standards.
Work with teams to ensure successful transfer of new products to manufacturing. Review production processes for quality of Process Validation.
Provide input to the creation of Design Verification and Validation protocols and test reports.
Provide guidance and direction for sample size and statistical analysis for testing.
Provide guidance and/or training to project teams on procedures, Design Verification and Validation, statistical methods and Design Controls.
Review Design History Files for conformance to applicable requirements.
Supports Regulatory Affairs regarding regulatory submissions e.g. 510(k) submissions containing medical device software.
Understand and be able to review software development lifecycle records for compliance with good documentation practices.
Maintain a complete awareness of the cost of quality and promote activities to monitor and reduce quality costs. Provide external supplier support as required.
May be responsible for specific SME (Subject Matter Expert) support, general improvement projects and support of CAPAs.
Education : Bachelor's Degree in Computer Science, Engineering or related technical field required. Master Degree or equivalent preferred.
Experience: 4-6 years
Experience of working on either of healthcare software lifecycle phase like design and development, testing, or customer facing activities.
Experience of healthcare software (medical device software or EMR, EHR) related customer requirement gathering, solution development, verification and validation testing, customer acceptance, complaint handing is preferred.
Experience of working in regulated industry of medical device is added advantage.
Working knowledge of software development and/or electrical/mechanical engineering.
Experience of working with healthcare provider that follows FDA Design Controls, ISO 13485 and other medical device regulations.
Professional certification (i.e. SQA-Software Quality Assurance, Certified Internal/Lead Auditor for ISO 13485) is is added advantage.
Requires excellent written and verbal communication skills.
Ability relocate to work location to work with geographically diverse teams.
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.
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Together, we can beat cancer.
Imagine a world without fear of cancer. We do, every day. Varian Medical Systems 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.
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, 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.