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Quality Engineer in Big Lake, MN at Volt

Date Posted: 1/29/2019

Job Snapshot

Job Description

Volt workforce solutions is seeking an Advanced Quality Engineer for our client in the Big Lake, MN area.  

About Our Client:

An internationally renowned manufacturer of industrial, orthopedic, traumatological spinal and dental implants and instruments.  They offer comprehensive production capacities and top-level quality management systems.

Position Summary:

This position is responsible for the transfer to production of new projects; the validation of manufacturing software or equipment; managing the change request from the suppliers or to the customer, as per ISO 13485 & FDA standard and internal/customer requirements; assuring compliance to and providing guidance regarding interpreting governmental regulations and ISO 13485 standards in link with the AO Quality Engineer activities.

Key Responsibilities:

This position is primary responsible for:

  • The transfer to production of the new product introduction.Transfer to production starts when the first batch is considered closed. This definition can be adjusted depending of the complexity of a project or the NPI workload. Transfer to production include optimization of the process and the documentation (including inspection WI, inspection and control plans, operator training, PFMEA
  • Managing the change request from a supplier and assessing its impacts internally and for the customer.
  • Managing and submission of the change request to the customer
  • Being the point of contact for the changes for the customer or the supplier
  • Supporting the validation ( software or equipment, in link with production)
  • Compiling and analyzing statistical data linked to SCR or validation, in order to assess process capabilities and control processes; Gauge Repeatability and Reproducibility (GR&R) and Statistical Process Control (SPC) studies.
  • Being the Validation SME
  • Create or update QMS documentation

Required Qualifications:

  • Bachelor degree in Manufacturing Engineering or related field.    
  • Minimum two years relevant experience / five years for senior position.
  • Experience developing manufacturing quality plans.
  • Experience conducting process capability, GR&R, PFMEA and SPC studies.   
  • Experience working in an ISO environment, preferably ISO 13485.
  • LEAN / Six Sigma training and demonstrated application. 
  • Proficient PC skills in a Windows environment.
  • Effective written and verbal communication skills.
  • Strong interpersonal and teamwork skills.

Preferred Qualifications:

  • Experience in a precision machine shop environment.
  • Experience working within a CAPA program.
  • Demonstrated use of structured problem-solving methods (i.e. 8D).
  • Experience in internal and supplier audits.
  • Experience using an ERP system.

Our client offers fantastic benefits, and a long term- career opportunity!

Volt is an Equal Opportunity Employer