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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