Ascensia Diabetes Care Looking for Senior IT Quality & Compliance Engineer at Thane, Maharashtra Full Time

What you will be doing:
Lead software projects and process improvements for the Global Quality organization related to the introduction and maintenance of software applications used to support the Quality System.

Work with Quality management and stakeholders on goal and objective setting as well as strategy development to ensure process improvement goals and objectives are in alignment with business needs and regulatory requirements. Develop proposals and associated funding requests for projects.

Ensure software process compliance as part of software implementations related to Quality System projects and manufacturing related software, including the activities managed by subcontractors and suppliers.

Provide guidance to software development teams regarding software process implementation on projects. Address questions about software processes and process compliance issues throughout the project lifecycle.

Provide Quality oversight of the software change management process.

Ensure that internal quality audits effectively support software quality compliance requirements.

Participate on Quality teams, peer review teams, and Technical Review Boards as requested in support of software and system development projects and activities.

Serve as a SME during supplier quality audits related to software compliance and as a reviewer of software-related supplier Quality Agreements, audit plans and reports in cooperation with the Supplier Quality organization.

Develop and maintain metrics for the Quality System software applications to measure process performance and to direct improvement initiatives.

What you need to succeed:
Bachelor’s Degree ideally in Computer Science, Software Engineering, Software Quality or related field (advanced degree a plus).

Minimum 5 years in software development and/or software quality, with technical software engineering experience (design, coding, testing) essential.

Working knowledge of ITIL practices and application of these practices in a life sciences industry.

Knowledge of medical device regulatory requirements including 21 CFR 820 and 11, in addition to ISO 13485. Knowledge of GAMP 5 and AAMI TIR36 a plus.

Ability to work with business process owners to develop requirements and metrics supporting Quality System software applications.

Knowledge of ERP, CRM and product change control software applications is a plus.

Experience in auditing; lead auditor certification a plus.

Must be able to work effectively with a diverse group of people, including senior management, project managers and software practitioners.

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