Senior Engineer, Quality Assurance

Overview

Senior Engineer, Quality Assurance supporting new product development and sustaining Quality Engineering and Assurance activities for medical device hardware and software, under the direction of a supervisor.

What you'll do

• Ensure activities within the Product Development elements are performed consistent with the Design and Development Plan, Change Plan and Quality Planning.
• Provide Quality Assurance of the Product Development and Lifecycle Management process.
• Ensure compliance and approval of PDLM records to Baxter procedures throughout the product lifecycle.
• Collaborate with regulatory affairs as needed to guide teams in meeting quality and regulatory requirements based on the regulatory plan, strategy or assessment.
• Collaborate with teams to provide guidance for meeting Baxter Requirements and External Quality Standards as appropriate.
• Ensure compliance of the Risk Management File.

What you'll need

• BE/Master's or equivalent in Engineering or equivalent field.
• 6-10 years in a related Quality or Engineering field in the medical products industry.
• Strong interpersonal, communication, influencing and negotiation skills.
• Strong analytical and problem-solving skills.
• Working knowledge of FDA Regulations.
• Demonstrated ability to lead others within small project or investigational environments.
• Good technical overview of medical device verification and validation.
• Good understanding of FDA QSR Part 820, ISO 13485, EU MDD / EU MDR.
• Broad working knowledge of Medical Device Software Development Life Cycle and IEC 62304.
• Basic understanding of medical device manufacturing process.
• Good understanding of requirements for Calibration and Qualification of Test and Measurement equipment in labs used for Verification and Validation.

Nice to have

• ASQ (e.g., CQE, CMQ/OE, etc.) and/or Six Sigma certification.

Details

• Location: Bangalore, Karnataka.