Sr. Quality Engineer in Big Lake, MN at Volt

Date Posted: 11/1/2018

Job Snapshot

Job Description

Great opportunity in the North Metro for a senior level Quality Engineer.  Selected candidate must have technical leadership and be willing to mentor others.  Prior experience validating equipment or Product is a must.  

Key areas of responsibility: Validating equipment/product processes.  Interface with client to collaborate on the development of new product processes. Some design and SPC experience.

The ideal candidate is well versed in ISO 13485, but will  be open to people from any regulated industry as long as they are strong in the technical piece.

This position is responsible for developing and maintaining:

  • Manufacturing quality plans along with project-specific quality plans.
  • Compiling and analyzing statistical data in order to assess process capabilities and control processes.
  • Investigating and resolving CAPAs.  
  • Performing internal and external ISO audits, assuring compliance to and providing guidance regarding interpreting governmental regulations and ISO 13485 standards.  I
  • Identifying continuous improvement opportunities.
  • Preparing required quality documentation, publishing quality metrics and maintaining and updating quality procedures.

Key Responsibilities:

Must Haves

1.  Develop and maintain manufacturing quality plans for the facility, including inspection and control plans, and ensure adherence to and the proper execution.

2.   Develop and maintain project-specific quality plans, including establishing quality requirements and standards for projects, while adhering to the customer requirements and working as part of a cross-functional team.  Measure and publish project-quality costs.

3.   Compile and analyze statistical data in order 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.

4.   Investigate and resolve all assigned Corrective And Preventative Actions (CAPAs).

5.   Perform both internal ISO audits and external supplier audits.  Participate in the supplier certification process and develop qualification requirements for purchased components and services.

Like to have:

6.   Assure compliance to and provide guidance and expertise regarding interpreting governmental regulations, ISO 13485 standards and internal Quality policies in order to assure compliance.

7.   Identify continuous improvement opportunities and support efforts in order to implement LEAN principles throughout the organization. 

8.   Prepare required quality documentation and reports.  Publish and distribute quality metrics.

9.   Maintain and update quality procedures.

10. Other duties as assigned.

Required Qualifications:

  • Bachelor degree in Manufacturing Engineering or related field.   
  • Minimum two years relevant experience.
  • 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, and conducting internal and supplier audits.
  • 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 using an ERP system.