BioTalent is partnered with a medical device manufacturer focusing on analytical and measurement equipment. They're seeking a Quality Engineer to join their team focusing CAPA management and alignment with federal standards.

Responsibilities

• Performing solo CAPA management for relevant Quality CAPAs including Failure investigations, verification of effectiveness, implementation, and any needed training.
• Design and implement methods for process control, process improvement, testing and inspection.
• Ensure all products and procedures are compliant with relevant ISO, FDA, and MDR requirements (ISO 13485, ISO 14971, etc).
• Initiate engineering change orders to correct drawings, specifications, and Quality System Process/Procedures, and manage/reconcile issues with the document control system (QMS included).
• Initiate and facilitate continuous improvement projects for Quality Systems and support continuous improvement.
• Participate in internal and external quality audits.

Qualifications

• Bachelor's degree or equivalent in Mechanical, Electrical, or Manufacturing Engineering
• 3+ years' of industry experience
• Strong knowledge of quality tools used in the industry.
• Prior experience in medical device and/or life sciences is mandatory.
• Experience with electrical component inspection and assembly is ideal.