Senior Quality Assurance Engineer

7 days ago


Saint Paul, Minnesota, United States LanceSoft, Inc. Full time
Job Title: Senior Quality Assurance Engineer

LanceSoft, Inc. is seeking a skilled Senior Quality Assurance Engineer to join our team.

Estimated Salary: $120,000 - $150,000 per annum

Job Overview

We are looking for a highly motivated and experienced Senior Quality Assurance Engineer to lead our risk management activities, including analyzing field data to support Failure Mode Effects Analysis and Hazard Analysis.

You will be responsible for supporting Test and Inspection Method development, including Method Validation activities, as well as Design Verification and Design Validation planning and execution.

Your key responsibilities will include maintaining high standards for Device History File (DHF) content completion, integrity, and regulatory / standards compliance; collaboratively identifying, communicating, and resolving gaps.

You will also be responsible for writing and revising SOPs, controlled forms, and related documents to ensure best practices and maintain compliance.

Furthermore, you will own Corrective Action/Preventive Action (CAPA) investigations.

Required Qualifications
  • Bachelor's degree within an Engineering field or a closely related discipline.
  • 5-8+ years of medical device engineering experience and demonstrated use of Quality tools/methodologies.
Preferred Qualifications
  • Bachelor's or advanced degree in Mechanical or Biomedical Engineering.
  • Prior experience with Cardiovascular medical devices.
  • Familiarity with 21 CFR Part 820, ISO 13485, ISO 14971, EUMDR, and MDSAP.
  • Solid verbal, written, and interpersonal skills with ability to effectively communicate at multiple levels in the organization.


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