Engineer Sr., Quality in Minneapolis, MN at Volt

Date Posted: 8/27/2019

Job Snapshot

Job Description

Quality Engineer

Minnetonka, MN

Long term-good chance of direct-local candidates only!

Volt Technical Resources is seeking a Quality Engineer for a leading manufacturer of medical devices for their Minnetonka location.

A Senior Quality Assurance Engineer assures products, processes, and quality records conform to quality standards and establishes compliance with the quality system.

Responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient safety and meeting business needs.

  • Accountable for leadership, decision making, and oversight of the quality systems, including CAPA (Corrective and Preventive Action) systems. Works with and influences key stakeholders to develop and maintain QA procedures, forms, and systems.
  • Develop and lead training for QA systems. Influence and guide other team members with product review and analysis for QA activities. Maintain databases and record storage for QA systems. Process QA requests, ensuring owners are assigned, and timely responses are provided in alignment with quality goals.
  • Lead meetings and communications for QA system information, concerns, and updates. Lead and mentor others with QA data analysis, trending, and reporting. High proficiency with reporting and publishing weekly, monthly, and quarterly metrics.
  • Lead Global CAPA team with training, CAPA oversight, and CAPA deliverables. Proficient as lead representative for presenting QA System to internal and external auditors.

Requirements:

  • Bachelor level degree in Engineering, Technical Field, or equivalent (advanced degree preferred)
  • 2-5+ years technical experience Previous Quality assurance/engineering experience and demonstrated use of Quality tools/methodologies
  • Detailed knowledge of FDA, GMP, and ISO 13485 

Candidates must be local for on-site interviews.

Volt is an Equal Opportunity Employer