QA Manager - Digital Health

Careernet

7 - 10 years

30 - 32 Lacs

bengaluru

Posted:11 hours ago| Platform:

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Skills Required

medical device techno functional agile sqa team test sdlc aerospace

Work Mode

Hybrid

Job Type

Full Time

Job Description

Key Skills:

Roles and Responsibilities:

Lead and mentor the SQA team in testing medical device software throughout the software development life cycle (SDLC).
Ensure compliance with applicable regulatory and quality standards, including FDA 21 CFR 820 and 11, IEC 62304, ISO 13485, ISO 14971, and FDA's General Principles of Software Validation.
Develop and implement testing strategies and plans to ensure high-quality software delivery.
Collaborate with cross-functional teams to define testing requirements and ensure alignment with project goals.
Manage multiple projects simultaneously, ensuring timely delivery and adherence to quality standards.
Communicate effectively with stakeholders, providing updates on project status and quality metrics.
Demonstrate a strong understanding of data integrity in regulated environments and ensure compliance in all testing activities.
Utilize Microsoft Office applications to document and report on testing activities and results.

Skills Required:

Strong expertise in medical device software testing and regulatory compliance
Deep knowledge of SDLC, software validation, and quality standards (e.g., ISO 13485, FDA 21 CFR)
Experience in leading and mentoring SQA teams
Familiarity with Agile methodologies and cross-functional collaboration
Excellent communication, reporting, and stakeholder engagement skills
Ability to manage multiple projects in a hybrid work setting
Experience working in regulated domains like Aerospace or similar is a plus

Education:

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