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Resmed
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Senior Product Quality Assurance Engineer

Senior Product Quality Assurance Engineer

Resmed

3 - 7 years

20 - 25 Lacs

Bengaluru

Posted:14 hours ago| Platform:

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Skills Required

Computer science Product quality QA Medical devices Quality standards Manager Quality Assurance ISO 13485 ISO Agile Hardware

Work Mode

Work from Office

Job Type

Full Time

Job Description

Job Summary

Product Quality supports and collaborates with the Engineering group and Cross Functional teams to enable a diverse range of product releases in an efficient and compliant way.

This role is focused on Strategy & Delivery Excellence - enabling velocity of product releases in alignment with established strategies, while also providing expertise to inform new strategies and improve design control processes, systems and tools.

Let s talk about Responsibilities

Author and communicate the project QA plan to enable new product implementation or changes to released product in an efficient way that satisfies ResMed s Quality System, regulatory requirements (e.g. ISO13485, CFR820, MDSAP), risk and project timing.
Apply balance of risk, regulatory intent and business needs to come to efficient and effective solutions. Define these strategies by close collaboration with stakeholders, considering benefit-risk, consistency across projects and starting with a yes mindset.
Regularly attend product cross functional team (XFT) meetings and actively participate in a positive, value-add manner.

Review Product Development deliverables to ensure they are completed accurately and efficiently. Conduct ongoing compliance reviews and provide reports as requested. Approve product releases based on successful completion of deliverables and compliance reviews.

Advocate customer expectations for product quality and reliability, by providing effective, targeted and timely input to decisions. Also identify, evaluate and escalate risks during development that could impact product quality/reliability/field performance. Effectively communicate these concerns and lead or participate in resolution of product quality/reliability risks with the XFT, QA, RA and other stakeholders.
Actively engage, collaborate and build relationships with global stakeholders and leaders, including Engineering, QA, RA and other cross functional partners to understand business/department needs, risks and concerns. Build this consideration into strategy planning and proposals to close gaps in an efficient, technical, and compliant manner
Identify areas and opportunities to improve QMS processes
Participate and lead support of internal and external audits within the relevant areas. Participate in relevant investigations as relate to design controls and ensure CAPA findings, risks, recommendations and outcomes are appropriate and are clearly documented and communicated.
To support projects across hardware & digital portfolios including but not limited to projects like NPI devices, SaMD, AI/ML models, Platform, IoT projects etc.

Let s talk about Qualifications and Experience

Required (Qualifications/experiences that are an absolute must for the position)

Degree in Engineering, Computer Science, Science or other tertiary qualifications deemed appropriate for this position.

Strong understanding of MDSAP, FDA, MDD/MDR and ISO Quality standards/regulations, including ISO13485, ISO14971 and IEC62304 for software development. e.g. Agile, DevOps.

Maintain knowledge of current good design practice for hardware and software in both medical and adjacent industries.

Experience within product development environment

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Resmed

Healthcare - Medical Devices

San Diego

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Senior Product Quality Assurance Engineer