quality engineer in Big Lake, MN at Volt

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

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