Senior Engineer, Quality Assurance

Baxter International Inc.; Bengaluru; Vor Ort; INR 1.500.000 - 2.500.000; Vollzeit

Zusammenfassung

Baxter International Inc. is seeking a Quality/Engineering professional to support new product development and sustaining activities for medical devices.

The role focuses on ensuring design control, lifecycle management, and regulatory compliance across product lifecycles. Responsibilities include QA activities for development and lifecycle processes, PDLM record approvals, and collaboration with Regulatory Affairs to meet FDA, ISO, and EU standards.

Qualifikationen

• BE/Master's in Engineering or related field.
• ASQ and/or Six Sigma certification preferred.
• Strong interpersonal/communication skills.
• Strong analytical and problem-solving skills.
• Working knowledge of FDA Regulations.
• Demonstrated ability to lead others within small project 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.

Aufgaben

• Ensure activities within the Product Development elements align with the Design and Development Plan, Change Plan and Quality Planning.
• QA of the Product Development and Lifecycle Management process.
• Approve PDLM records to Baxter procedures throughout the product lifecycle.
• Collaborate with regulatory affairs to guide teams in meeting quality/regulatory requirements per plan.
• Collaborate with teams to meet Baxter Requirements and External Quality Standards as appropriate.
• Maintain compliance of the Risk Management File.

Kenntnisse

Quality engineering

Regulatory knowledge

Leadership

Analytical thinking

Problem solving

Communication skills

Ausbildung

BE/Master's in Engineering

Jobbeschreibung

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.