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Principal Eng, Quality Assurance

8+ years
Not Disclosed
10 Jan. 16, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./BS Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Principal Engineer, Quality Assurance
Req #: JR-156486
Location: Bengaluru, Karnataka, India
Job Type: Full-Time


Overview

Baxter’s mission is to save and sustain lives. As a part of the Quality team, you will play a critical role in ensuring patient safety and maintaining quality standards throughout the product lifecycle. Your contributions will directly impact millions of patients worldwide and contribute to innovations in healthcare.


Essential Duties and Responsibilities

  • Represent the Quality function for product support and lifecycle management.
  • Support process improvement efforts and assist in decision-making.
  • Ensure compliance and approval of Product Development and Lifecycle Management (PDLM) records per Baxter procedures.
  • Provide expertise in generating design plans and reviewing design inputs, outputs, verification, validation, and design transfer strategies.
  • Support risk management activities for new product development (NPD) and sustaining engineering projects.
  • Facilitate post-market activities, including complaint investigations, trending, CAPA, and failure analysis processes.
  • Collaborate with global manufacturing facilities for supplier and manufacturing changes.
  • Participate in compliance audits and regulatory inquiries, including FDA and ministry of health (MOH) inspections.
  • Review and approve specifications, procedures, protocols, and documentation.
  • Conduct audits and contribute to continuous improvement initiatives.

Qualifications

  • Education: Bachelor’s degree in Engineering.
  • Experience: 8+ years in Quality or Engineering roles in the medical products industry.
  • Certifications (Preferred): ASQ (e.g., CQE, CMQ/OE) or Six Sigma certification.
  • Strong skills in interpersonal communication, problem-solving, and negotiation.
  • Proficient in FDA regulations, medical device verification, validation, and test automation.
  • Knowledge of global standards such as 21 CFR Part 820, ISO 13485, EU MDD/EU MDR, and IEC 62304.
  • Understanding of medical device manufacturing processes, calibration, and test equipment qualification.

Why Join Baxter?

  • Opportunity to make a meaningful impact on global healthcare.
  • Work with cutting-edge technologies and innovative medical solutions.
  • Collaborate with a team that values diversity, equity, and inclusion.
  • Access to continuing education and professional development opportunities.

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