Quality Engineer

Quality Engineer

The Quality Engineer (QE) plans, directs and monitors the quality management system (QMS) and monitors and verifies SW quality activities at the facility in Bangalore, India.

The QE will be a subject matter expert for the eQMS, Greenlight Guru.

The QE will ensure that the software development lifecycle (SDLC) processes are in accordance with established policies and procedures.

The QE will be a main point of contact and document any customer complaints. The QE will ensure that the site operates in a state of compliance with internal policies and procedures as well as domestic and international regulations and standards (e.g. CDSCO, FDA, ISO).

The QE will provide leadership and technical support for the QMS including but not limited to the Internal Audit, CAPA, customer complaint handling, training, and product and process improvement projects.

QE will:

• Verify that Software released follows the SDLC and applicable product realization procedures
• Lead CAPA activities for India
• Establish and implement practices and procedures that reinforce product and services quality and compliance with the QMS
• Develop and implement a continuous improvement program for the India site.
• Review and approve SW, process, and product changes orders
• Ensure appropriate document control activities are in place
• Lead internal, process and supplier audits, resolution of audit and inspection findings and liaise with auditing groups and inspectors through all stages of the audits
• Maintain calibration records for measuring equipment

Must Have: Minimum Requirements

A Bachelor's Degree in a technical field (science, technology, engineering, or mathematics) with 5+ years related Quality Engineering and Software Quality experience in a medical device company or other regulated, critical end-use product industry.

• Demonstrated analytical and data-based decision-making skills
• Demonstrated experience in an ISO 13485:2016 QMS environment
• Experience with SDLC ticketing / tracking systems
• Knowledge of India (CDSCO) and US (FDA) medical device regulations

Nice to Have:

• Experience with 3rd-party ISO 13485 certification audits.
• Experience with critical-to-safety systems that include both software and hardware.
• Experience with JIRA and Greenlight Guru.
• Experience working at a medical device manufacturer
• Experience with patient monitoring devices.
• ISO 13485:2016 Internal Auditor Certification
• Six Sigma Black Belt and/or Lean Manufacturing certification and/or statistical sampling and analysis preferred.

Must be able to travel domestically and internationally, up to 20%.