Engineer Sr., Quality in Minnetonka, MN at Volt

Date Posted: 1/12/2021

Job Snapshot

Job Description

Medical Device Sr. Quality Engineer

24 mths-up to $46.00 hr.-Minnentonka

Volt Technical Resources is seeking a Sr. Quality Engineer with medical device experience.  You will be assuring products, processes, and quality records to conform to quality standards and establishes compliance with the quality system.

  • Develop and lead training for QA systems. Influence and guide other team members with product review and analysis for QA activities.
  • Process QA requests, ensuring owners are assigned, and timely responses are provided in alignment with quality goals.
  • Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements. Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements,  

Required

  • 3+ years technical experience Previous Quality assurance/engineering experience in medical devices. 
  • Detailed knowledge of FDA, GMP, and ISO 13485 Solid communication and interpersonal skills Demonstrated and impactful project management and leadership skills, including the ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner
  • Advanced computer skills, including statistical/data analysis and report writing skills Prior medical device experience required ASQ CQT, CQE, CQA certification preferred Six Sigma root cause analysis/problem solving training and experience preferred.

Volt is an Equal opportunity Employer