Are you a Senior Executive – Quality Assurance (QA) passionate about ensuring compliance, quality, and excellence across every stage of the product lifecycle? If so, this opportunity could be for you! Join us in Hyderabad at Oyster Medisafe, a pioneer in medical devices, where your expertise in quality systems, regulatory standards, and continuous improvement will be valued and celebrated. Take the next step in your career with us and play a vital role in shaping the future of healthcare through quality and safety.
Key Responsibilities
- Lead validation activities for equipment, processes, software, and sterilization in compliance with ISO 13485, EU MDR, and applicable regulatory standards.
- Plan and manage calibration activities, ensuring all equipment maintains valid calibration status and audit-ready documentation.
- Oversee label management through the NiceLabel system, ensuring accurate artwork control and seamless label printing operations.
- Support quality systems including documentation control, deviations, change management, and internal audits.
- Actively participate in CAPA processes, from root cause analysis to implementation and tracking in the B.TraQS system.
What You Will Bring to the Team
- 5–7 years of hands-on quality management experience in medical devices or plastics, with strong knowledge of injection molding and extrusion processes.
- In-depth understanding of global regulatory requirements including ISO 13485, EU MDR 2017/745, CE marking, and Indian Medical Device Rules.
- Strong documentation, system-handling, and audit management skills with a high level of accuracy and compliance focus.
- Clear communication, collaborative mindset, and the ability to drive quality initiatives across cross-functional teams.
What sets B. Braun apart?
Oyster Medisafe Pvt. Ltd., a B. Braun group company in Hyderabad, manufactures CE certified hypodermic syringes, needles and IV sets. Our products are used in hospitals, private practices, and emergency services, establishing us as a key player in the medical device industry. Our core values of Innovation, Efficiency, Sustainability, Trust, Accountability, and Diversity foster a performance-driven culture where we challenge each other constructively to grow personally and professionally.Recognized through awards such as 'Dream Companies to Work For' and 'Great Place to Work,' we invite you to join our team driven by a shared vision - to protect and improve the health of people around the world.
What can we offer you?
Convenient transport and subsidized canteen services.Mediclaim and Life Insurance.Learning programs and workshops to drive your development.Mental Wellness Support with counselling and mindfulness sessions.Paternity & Birthday Leave for life’s special moments.Fun activities and team building events.
What’s next?
Upon receiving your application, our dedicated Talent Acquisition team will review your application. If you stand out, you’ll be invited to engage in dynamic interviews, ranging from phone calls to video chats and in-person meetings. Throughout this process, we will keep you informed and inspired with regular updates and feedback. Finally, if you shine through and decide to join us, we will lead you into our seamless onboarding experience. Join us and be part of something extraordinary!We appreciate different perspectives, thoughts, experiences and backgrounds. By strengthening an appreciative, inclusive, respectful and equal working environment, we create a culture in which all our employees feel free to be who they are. To find out more about our commitment to diversity click here
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