Job Description

Summary Becton Dickinson, a global medical technology company focused on addressing many of the world\'s most pressing and evolving health needs. With our combined technology and expertise, we will become a global leader helping to transform the quality and cost of care for patients and clinicians worldwide. Join us in our mission to improve the future of healthcare and help all people lead healthy lives.

We have an immediate opening for a highly motivated, results-focused professional to join our team, and are adding to our staff as a Quality Engineer. The Quality Engineer\'s primary responsibilities are to support ISO 13485:2016 certification, including but not limited to documentation, facilitating and supporting Internal audits, preparing reports, follow up for NC closure, etc., supporting new product development activities for assigned products, maintain compliance to company procedures and external standards, manage design history files, review verification and validation documentation, collaborate on product development deliverable documentation.

• Supporting ISO 13485:2016 certification activities and maintaining the required documentation for Surveillance/compliance audits
• Interact/communicate with project teams to effectively facilitate and train them for audit findings closure and stay in compliance to Organizational processes.
• Provide clarification and guidance to teams on overall quality system with emphasis in design controls.
• Manage all quality aspects of the design control process for Software products.
• Responsible for review and/or approval of design history file documentation in support of design controls.
• Identifies areas requiring quality improvement and work with site Quality manager to initiate necessary action plans for implementation.
• Ensure product Design History Files are complete and auditable.

What is expected for success in this role:

• Exposure to ISO 13485 or facilitating the organization to achieve the certification is a must.
• Communicates effectively within quality team, raise red flags on time and helping effectively to sustain ISO certification.
• Excellent organizational skills to effectively manage projects in parallel.
• Ability to quickly learn, understand and comprehend highly technical concepts.
• Uses analytical thinking and reasoning to anticipate implication/conclusions of a complex situation or issue.
• Applies understanding of regulatory requirements (FDA, ISO, etc.) to support work.
• Good understanding of ISO 13485, Agile, Design Controls and Risk management methodologies.

Primary Work Location IND Chandigarh - DLF IT Park

Additional Locations

Work Shift

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