Senior Engineer, Quality Assurance

Baxter Healthcare; Bengaluru; In loco; INR 2.500.000 - 4.000.000; Tempo pieno

Descrizione del lavoro

Baxter Healthcare in Bengaluru, India, seeks a seasoned Quality Engineer to support new product development and sustained QA for medical device hardware and software. Under supervision, you will ensure Development Plans and Quality Planning are followed, lead small projects, and collaborate with regulatory affairs to meet FDA/ISO/EU requirements.

You will bring 6–10 years of medical devices experience, an engineering degree, and ASQ/Six Sigma certifications.

Competenze

• BE/Master's or Equivalent in Engineering with 6-10 years in medical products.
• ASQ (e.g., CQE, CMQ/OE, etc.) and/or Six Sigma certification highly preferred.
• Strong interpersonal/communication/influencing/negotiation 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.

Mansioni

• Ensures 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.

Conoscenze

Quality Engineering

Regulatory knowledge

Leadership

FDA Regulations

Analytical skills

Communication skills

ISO 13485

IEC 62304

V&V knowledge

Calibration & measurement

Formazione

BE/Master's in Engineering

Descrizione del lavoro

This is whereyour 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, please click on the link here and let us know the nature of your request along with your contact information.

Tower B, 16th Floor|Karnataka- 560 048|Karnātaka|India