Quality Engineer I in Minneapolis, MN at Volt

Job Description

Quality Engineer (12-month contract)
Plymouth, MN

Volt has partnered with a growing client of ours in search of a Quality Engineer! In this role, you will consult with Manufacturing, Information Management, Research Development & Engineering, Quality Assurance Operations and Product Performance Analysis teams to ensure compliance to LifeScan software development procedures and industry regulations.

Responsibilities:

• Review and approve deliverables of the software development lifecycle.
• Lead teams in performing Hazard Analysis.
• Assist teams in developing Standard Operating Procedures and Work Instructions for software development activities that meet their specific needs.
• Provide training for select software development activities for LifeScan.
• Write and execute test protocols and reports.
• Execute and support on-time completion of Design Control Deliverables.
• Create the FAI (First Article Inspection), SIR (Special Inspection Requests) and RIP (Receiving Inspection Process) documents.
• Complete Document Change Request Reviews in a timely and objective manner.
• Accountable for Design Verification and Validation planning & execution, including active cross-functional root-cause analysis investigation & resolution activities.
• Lead or support Risk Management activities from product Concept through Commercialization.
• Support receiving inspection method development.
• Ensure DHF content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps.
• Support objective component specification definitions, supplied component sampling plan development, and vendor qualifications.
• Support execution of biocompatibility and sterilization qualifications.

Requirements:

• Bachelor’s Degree.
• A minimum of 0-3 years’ technical.
• Ability to work in a highly matrixed and geographically diverse business environment.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
• Ability to identify and solve problems and work independently with little oversight.

Volt is an Equal Opportunity Employer