quality engineer in Big Lake, MN at Volt

Date Posted: 11/5/2018

Job Snapshot

Job Description

Quality Engineer (Direct hire)
Becker, MN

Summary:
This position is responsible for assisting daily production, work on continuous improvement of his/her cell, participating to the LEAP activities like PSM, managing the customer complaints and the CAPA/NCR linked to his/her scope of activities, assuring compliance to and providing guidance regarding interpreting governmental regulations and ISO 13485 & FDA standards in link with the Manufacturing Quality Engineer activities. The Manufacturing QE acts as an Operational Lead for the QAR (Quality Representative) of his/her cell.

Responsibilities:

  1. For the Quality topics, assisting daily production and participating to achieve the objectives determined with the manager.
  2. Create/Maintain updated quality plans and work instructions, inspection and control plans, inspection work instruction, PFMEA, including the respect of quality requirements and standards.
  3. Act as an Operational Lead with the QAR working in the same cell, which include but not limited to work with the Planner to define the inspection priority, manage the daily QAR PSM1, help to harmonize the QAR practices, escalation of issues when applicable.

The HR activities are supervised by the QA manager, in link with the Manufacturing QE such as defining the QAR training needs, preparation of performance reviews, problem resolution.

  1. Identify continuous improvement opportunities and support efforts to implement LEAP principles throughout the organization, such as participating to PSM or LEAP workshop. 
  2. The NCR and the CAPA investigation linked to his/her cell, with respect to the due date define and using problem solving tools when applicable and working as part of a cross-functional team. 
  3. Participate and be the QA lead for validation of equipment repairing with Maintenance, and IT.
  4. Interface with client and the supplier in case of Customer complaints or supplier SCAR.  (Lead)
  5. Transfer knowledge experience from the Advanced Operations Quality Engineer when a project is mature enough to be considered as production phase.
  6. Contribute to the cell employee training.
  7. 6 Sigma, statistical techniques and 8D problem solving SMEs for his/her cell.

These position secondary responsibilities are:

  1. Train new employee for the Quality induction part.
  2. Be back up of the other Manufacturing QE.
  3. Be the secondary backup of his/her Advanced Operations QE.
  4. Perform internal or external audits.
  5. Compile and analyze statistical data to assess process capabilities and control processes and conduct Process Failure Mode Effects and Analysis (PFMEA), Gauge Repeatability and Reproducibility (GR&R) and Statistical Process Control (SPC) studies.

Qualifications:

  • Bachelor’s degree in manufacturing engineering or related field.    
  • Minimum two years relevant experience / five years for senior position.
  • Experience working within a CAPA program.
  • Experience developing manufacturing quality plans.
  • Experience conducting process capability, GR&R, PFMEA and SPC studies.   
  • Experience optimizing processes to achieve ongoing cost reductions.
  • Experience working in an ISO environment, preferably ISO 13485.
  • LEAN / Six Sigma training and demonstrated application. 

Preferred Qualifications:

  • Experience in a precision machine shop environment.
  • Demonstrated use of structured problem-solving methods (i.e. 8D).
  • Experience in internal and supplier audits.
  • Experience using an ERP system.
  • Experience of managing a staff or cross functional team lead.

Volt is an Equal Opportunity Employer