Specialist-Quality Operations

Sep 29, 2021

Job Description

28,000 associates of more than 100 nationalities deliver high quality and affordable medicine on time, every time, safely and efficiently.

Your key responsibilities:
Your responsibilities include, but not limited to:
• Prepare and update Post Market Surveillance (PMS) plan, related activities & report for medical devices.
• Maintenance of Device Master Record (DMR), identify the gaps using manufacturing expertise, provide recommendations in compliance with the applicable standards (ISO, FDA, MDD/MDR, etc.,)
• Ensure timely completion and quality of the assigned Design History Files especially risk management files. Ensure compliance with ISO 13485, ISO 14971 and relevant standards in all development and commercialized projects assigned.
• Contribute or lead specific Risk Management Activities within projects, as agreed with project leaders. Initiate, manage and contributes to the Change Control process in Agile PLM and Trackwise
• Assessing the quality, performance, efficacy and safety of a medical device. Perform proactive analysis for warnings of potential quality issues, benchmark results with competitor devices, or field-based inputs to risk control measures defined in the device Risk Management File (RMF).
• Designing the QlikSense Enterprise environment for data analysis and KPI reporting. And maintaining data visualization tools like QlikSense.

Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.

Minimum Requirements

What you’ll bring to the role:

• 3+yrs of experience in Writing technical documentation related to medical devices
• Good understanding of compliance with ISO 13485, ISO 14971 and relevant standards in all development and commercialized projects.
• Experience in reviewing, perform data admin check and authoring the documentation in the design history files.
• Hands on experience in design and issuing the quarterly / annually post market surveillance (PMS) plan for medical devices.

Why Novartis?
769 million lives were touched by Novartis medicines in 2020, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.

We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.

We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!

Imagine what you could do here at Novartis!

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
Novartis Technical Operations
Hyderabad, AP
Full Time
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Specialist-Quality Operations

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