QA Engineer – CAPA Specialist | Varian | Pune, Maharashtra, India
Position: QA Engineer – CAPA Specialist
Location: Pune, Maharashtra, India
Company Description
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.
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Job Description
- Ability to manage multiple projects simultaneously without supervision.
- Provide authoritative guidance to all appropriate regulations, safety standards, and internal Quality System processes.
- Ability to monitor and analyze process and product data statistically and identify improvement opportunities.
- Ability to write/review software test scripts manual / automated Able to work with project teams effectively.
- Gains buy-in on new ideas and is able to give feedback without offending.
- Must be able to manage and meet personal commitments.
- Not only provides input but also provides potential solutions.
- Excellent communication, problem-solving, and interpersonal skills (teams).
- Effective skills in analytical thinking and problem-solving.
- Team player.
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Qualification and Skills
- Bachelor’s in engineering, healthcare or science
- 3-5 years of experience in engineering or technical operation
- Experience of tools, techniques or methodologies of quality assurance and/or CAPA system
- Medical device experience preferred
- Advanced computer skills – Data analysis, report building/writing.
- Strong verbal and written communication ability to work with the global workforce at multiple levels
- Working hours overlaps with EU and USA, Ability to work during a European or US time zone to work with geographically diverse and international teams.
- Key Words: ISO 13485, FDA Quality System Regulation 21 CFR 820, EU-MDR 2017/745, MDD 93/42/EEC, CMDR SOR/98/282
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