- 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.
- BS engineering and 6+ 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 and Design Controls requirements.
- Demonstrated ability to lead others within small project or investigational environments.
- Good understanding of 21 CFR Part 820, ISO 13485, EU MDD / EU MDR.
- Broad working knowledge of Medical Device Software Development Lifecycle and IEC 62304.
- Good 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.
Senior Eng, Quality Assurance - Bengaluru, India - Baxter
Description
This is where you save and sustain lives
At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.
Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.
Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.
Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.
For us, working at Baxter is not just a job—it's a calling. Our mission to save and sustain lives unites us.
We are driven not by what will be easy, but what will transform global healthcare for generations to come. Together, we create a place where we are happy, successful and inspire each other as we pursue rewarding careers.
We're grateful you're interested in continuing your career journey with Baxter. This is where your purpose accelerates our mission and make a positive impact on millions of people around the world.
Job Summary:
As Senior Engineer- Quality Assurance, you will lead and support PDLM deliverables review and approval for PSS and GSS multiple product lines. You will be responsible to provide process consultancy to the R&D teams for PSS and GSS.
Essential Duties and Responsibilities:
Your Team:
Reporting to Manager – Systems for PSS/GSS, you will be responsible for delivering quality assurance related deliverables for PSS/GSS product software and systems.
Your Location:
The role is located in the BRD facility in Bangalore India.
What You'll Bring: