Senior Engineer, Quality Assurance

Zvh; Bengaluru; On-site; INR 1,500,000 - 2,300,000; Full time

Job summary

Baxter is seeking a senior quality/engineering professional to support new product development and sustain Quality Engineering activities for medical device hardware and software.

The role involves ensuring QA across development, lifecycle management, and regulatory compliance, with collaboration across regulatory affairs to meet standards such as FDA QSR Part 820, ISO 13485, and IEC 62304.

Qualifications

• BE/Master's or equivalent in Engineering with 6–10 years in quality or engineering in medical devices.
• ASQ CQE and/or Six Sigma certification preferred.
• Strong interpersonal/communication/influencing/negotiation skills.
• Strong analytical and problem‑solving skills.
• Working knowledge of FDA Regulations.
• Demonstrated ability to lead small projects or investigations.

Responsibilities

• Ensures activities within Product Development are performed per Design and Development Plan, Change Plan, and Quality Planning.
• Responsible for Quality Assurance of Product Development and Lifecycle Management processes.
• Responsible for compliance and approval of PDLM records per Baxter procedures across the product lifecycle.
• Collaborate with regulatory affairs to guide teams in meeting regulatory requirements.
• Collaborate with teams to meet Baxter Requirements and External Quality Standards.
• Compliance of the Risk Management File.

Skills

ASQ CQE

Six Sigma

Interpersonal skills

Problem solving

FDA Regulations

Project leadership

Education

BE/Master's in Engineering

Job description

This is where your work makes a difference. At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. Here, you will find more than just a job—you will find purpose and pride.

Your Role at Baxter Under direction of supervisor, responsible for supporting new product development and sustaining Quality Engineering / Assurance activities related to medical device hardware and software.

What you’ll be doing

• Ensures that activities within the Product Development elements are performed in a manner consistent with the Design and Development Plan, Change Plan and Quality Planning.
• Responsible for Quality Assurance of the Product Development and Lifecycle Management process.
• Responsible for the 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/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.
• Compliance of the Risk Management File.

What you’ll bring

• BE/Master's or Equivalent in Engineering or Equivalent field with 6-10 years in related Quality or Engineering field in the medical products industry.
• ASQ (e.g., CQE, CMQ/OE, etc.) and/or Six Sigma certification highly preferred.
• Strong interpersonal/communication/influencing/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 & Measurement equipment in labs used for Verification and Validation.

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process,

No matter your role at Baxter, your talent, skills, and time has a direct impact on people's lives. Since 1931, we have been at the forefront of innovation by bringing smarter, more personalized care to patients around the world. Now, we're more determined than ever to make a lasting impact as we are redefining healthcare delivery across the care journey. Our Mission to Save and Sustain Lives motivates us as we create a culture in which each of us can succeed. This is where you belong.