Job Description

Exp - 5 to 10 years

Loc - Pune (Work From Office)

Job Posting Title

Engineer III, Quality Engineering

Summary

We have an immediate opening for a highly motivated, results-focused professional to join our team as a Quality Engineer. The Quality Engineer's primary responsibilities are to support new product development activities, maintain compliance to company procedures and external standards, manage design history files, review verification and validation documentation, participate in risk analysis activities, collaborate on product development deliverable documentation. Responsibilities also include being the quality and compliance representative for the assigned projects. We are ISO 13485 organization so exposure to the standard is desired.



Responsible for being the prime quality representative for design control projects - new product development as well as sustaining efforts.

Provide clarification and guidance to teams on overall quality system with emphasis in design controls.

Responsible for review and/or approval of design history file documentation in support of design controls.

Manage all quality aspects of the design control process. .

Work closely with Program Managers to ensure design deliverables are met and can be released to limited commercial and/or general release.

Works together with SW Quality Engineers to ensure effective verification of design requirements.

Active participant in the development of product requirement, product system hazard analysis and design reviews.

Identify and Setup Metrics framework required for monitoring of products.

Provide information / data for Senior / Management Review meetings.

Identifies areas requiring quality improvement and initiates and follows through plans of action necessary for implementation.

Ensure product technical files and Design History Files are complete and auditable.

What is expected of you for success in your role

Experience of process definition, Management Review dashboard setup & identifying and implementing best practices across the projects.

Responsible for identifying and driving quality initiatives.

Perform periodic audits covering process compliance, metrics and risk reviews aligned with organizational processes.

Participate in project meetings, drive discussions towards compliance with quality system and rigorous documentation to complete project deliverables.

Hands on experience on setting up automated dashboards using automated tool is good to have.

Verify external audit results, reporting to senior leadership and initiate necessary CAPA(corrective and preventive actions) if required.

Mentor and train fellow team members.

Building Process awareness engagements by providing necessary Process trainings, walkthrough of templates and tools.

Applies understanding of regulatory requirements (cGMP, FDA, ISO, etc.) to support work

Good understanding of Software Development Lifecycle, Agile, design controls and risk management methodologies.

Qualifications

Bachelor's degree in engineering, life sciences or Quality Management.

8+ years' experience in software quality.

Auditor certification from ASQ (CQA, CQE, CSQE, CMQ) is a definite plus.

Certified ISO 13485 auditor is desired.

Must be able to apply quality principles (ISO, 21 CFR, etc.) to the R&D environment.

Knowledge of software development life cycle and test methodology.

Experience dealing with SW only products highly desired

Note - It's contractual role of 7 months

Job Types: Full-time, Temporary
Contract length: 7 months

Schedule:

• Day shift

Work Location: In person