Manufacturing Quality Engineer - Lancesoft : Job Details

Manufacturing Quality Engineer

Lancesoft

Job Location : Saint Paul,MN, USA

Posted on : 2024-11-30T04:19:57Z

Job Description :

Job Title: Manufacturing Quality Engineer

Location: St. Paul, MN - 55117

Duration: 12 Months

What You'll Work On:

  • Lead Risk Management activities including analyzing field data to support Failure Mode Effects Analysis and Hazard Analysis.
  • Support Test and Inspection Method development including Method Validation activities.
  • Support Design Verification and Design Validation planning and execution, including cross-functional root-cause analysis investigation and resolution activities.
  • Maintain high standards for Device History File (DHF) content completion, integrity, and regulatory / standards compliance; collaboratively identifying, communicating, and resolving gaps.
  • Writes and revises SOPs, controlled forms, and related documents to ensure best practices and maintain compliance.
  • 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-Can Modify

  • Bachelor's or advanced degree in Mechanical or Biomedical Engineering
  • Prior experience with Cardiovascular medical devices
  • Familiar 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.

Apply Now!

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