Supplier Quality Engineer

New Brighton, MN

Job Description
Indrotec is seeking candidates for a contract Supplier Quality Engineer position to work at Cardiovascular Systems Inc. (CSI). This position provides engineering guidance and project team leadership for supplier quality through critical thinking, review, analysis and resolution of supplier quality issues.
Duties and Responsibilities
  • Ability to effectively communicate, facilitate and organize project activities relating to ensuring supplier quality. Develops and manages project schedules to ensure deadlines are met.
  • Serves as the primary Quality contact for suppliers and provides technical assistance to management for suppliers as requested.
  • Works with supplier development engineering to performs on-site annual and critical component supplier audits to ensure compliance with Quality Systems procedures and CSI requirements. Generates audit reports and ensures supplier audit findings are tracked to timely and closure.
  • Provides quality systems input to suppliers such as, but not limited to: statistical process control, gage R&R studies, and capability studies.
  • Resolves supplier quality issues at incoming inspection and the production line. Provides project team leadership and conducts investigations relating to supplier quality issues. Completes non-conforming material reports (NCMR), supplier requests for change (SRC), supplier corrective action requests (SCARs) and monitors follow-up with assigned supplier base.
  • Routinely reports on supplier performance per defined metrics to management and other team members.
  • Represent Quality during audits and interface with FDA, ISO, or any external auditor.
  • 4 Year / Bachelor of Science Degree in engineering, or science
  • 2-3+ years engineering related experience in a manufacturing environment, medical device industry preferred.
  • Familiarity with quality improvement tools, including statistical methods.
  • Working knowledge of ANSI standard sampling plans.
  • Demonstrated team leadership skills, interpersonal skills, organizational skills, verbal and written communication skills, and analytical skills and application of critical thinking.
  • Familiarity with personal computer software including work processing, spreadsheet, and statistical programs.

Post Date: 05.12.2022

Salary: $38.00 /hr - $45.00 /hr

Shift: 1st

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