- Lead establish and maintain quality System requirements in accordance with applicable quality procedures and applicable international and technical standards.
- Evangelize improvement initiatives and organizational changes related to business agility in your area of responsibility.
- Develop and lead a team of quality professionals aligned with quality system and business strategy to support quality compliance, and business growth, and improve product quality and customer experience.
- Communicate effectively in your area of responsibility to support implementation and address potential risks and business opportunities.
- Provide guidance and/or training regarding new or revised regulatory standards, quality system procedures, and process changes.
- Authorize and monitor design engineering projects in accordance with the quality management system and applicable product standards. Led and authorized product design reviews at various stages to ensure product quality and regulatory compliance.
- Manage quality audit program (internal /external) for the site and collaborate with other sites / global quality audit programs.
- Manage/maintain design history files and technical files for conformance and compliance with applicable regulations. Manage regulatory submissions to regulatory agencies and acquire necessary certification or license.
- Manage quality review board(s) with inputs of quality data points, and trend metrics and trigger data-driven decisions with improvement initiatives, corrective and preventive action.
- Bachelor's or master's degree in software engineering/computer science engineering or related technical field required.
- 8-10 years of experience in the medical device industry, preferably medical device software.
- 4-5 years of people management experience and drive/coach teams to the next levels
- 2-3 years of experience as a Quality System Auditor or equivalent experience.
- Professional certification (like Certified Internal/Lead Auditor, SQA-Software Quality Assurance, FDA-CFR-820, MDSAP, EU-MDR) is desirable.
- End-to-end product lifecycle experience, specifically in design quality assurance, risk management, technical file management, design transfer, supply chain management, regulatory submission, and post-market surveillance.
- Experience in Agile/Scrum software development methodology is preferred.
- Demonstrated expertise with FDA regulation, ISO 13485, ISO 14971, IEC 62304, MDSAP, IEC 60601, and applicable other medical device regulations.
- Working knowledge of software development lifecycle and SaMD regulations. Familiarity with radiotherapy equipment is preferred.
- Experience in managing/coordinating quality assurance activities in a cross-functional team environment
- Ability to work and influence geographically diverse and international workgroups including excellent communication and intrapersonal skills.
- Travel may be required – domestically and internationally.
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Quality System Manager - pune, India - 0548 Varian Medical Systems Int'l (India) Pvt Ltd
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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.
This role is responsible for ensuring quality compliance and robust medical device design development quality systems to satisfy international requirements and global regulatory needs.
Major responsibilities include, but not limited to:
Qualifications and Experience:
Attributes and skills :
Varian is required to comply with all local and applicable regulations that may be associated with vaccine requirements for certain roles.
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
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