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Vantive
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Senior Quality Assurance

Senior Quality Assurance

Vantive

6 - 11 years

5 - 9 Lacs

bengaluru

Posted:None| Platform:

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Skills Required

manager quality assurance iso 13485 analytical process improvement agile supplier quality management risk management product support sdlc recruitment

Work Mode

Work from Office

Job Type

Full Time

Job Description

Demonstrate quality assertiveness and be able to represent quality function in various roles such as

product support and lifecycle management.

Assist in decision making for process improvement efforts and participate in continual process

improvements.

Experience in assessing and developing procedures to meet Digital Health regulatory requirements and guidance.

Responsible for Quality Assurance of the Product Development and Lifecycle Management process.

Provide quality role in assisting with generating design plans, reviewing design inputs, outputs,

verification, validation and design transfer strategies for sustenance projects.

Support risk management activities for NPD and sustaining engineering products, supporting post market activities such as complaint investigation, complaint trending, CAPA and FA processes.

Supporting supplier quality management activities including collaborating with supplier management

teams and conducting supplier audits.

Support as a key quality representative in compliance audits and FDA/ministry of health (MOH) inquiries, FDA inspections and ISO/Notified body audits.

Collaborate with teams to provide guidance for meeting Vantive Requirements and External Quality

Standards as appropriate, including regulatory affairs to meet regulatory requirements.

Experience in working with requirements for Test Method Validation, Calibration and Qualification of Test & Measurement equipment in labs used for Verification and Validation and Computer System Validations.

BS engineering (Mechanical, Electrical and Electronics) and 6+ years in related Quality or Engineering field in the medical products industry.

Strong interpersonal / communication / influencing / negotiation skills.

Strong analytical and problem-solving skills.

Working knowledge of FDA Regulations and Design Controls requirements for non-active devices and active devices.

Experience in the application of design controls and compliance requirements in accordance with 21 CFR Part 820, ISO 13485, IEC 62304, ISO 14971, EU MDD / EU MDR, Agile SDLC.

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Senior Quality Assurance