Sr Engineer, Quality Assurance

Your Role at Baxter


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/Masters 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.

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.