Quality Engineer

Kelly Engineering is currently recruiting for a (Contract) (Quality Engineer) job located in Charlotte, NC. The Quality Engineer is responsible for a number of quality engineering functions, including design, manufacturing, sustaining, and supplier quality engineering, primarily identifying and driving the resolution of internal and external quality issues.  This is done through using internal Quality System processes, following external regulatory standards and regulations, and through direct interaction with internal functions on technical issues and solutions.  They will also be responsible for direct technical support of forward model engineering projects, the creation, review, and approval of engineering documentation, process and hardware verification/validation support, supplier quality activities, and the implementation of systemic improvements to the Quality Management System.

 

Essential Duties and Responsibilities:

  • Identify and drive the resolution of internal and external quality issues through ownership and use of the site risk processes
  • Own and drive CAPA projects to completion, to eliminate, or greatly reduce the cause(s) of product quality issues and process compliance issues
  • Provide hands on technical and quality system support for new product introduction (NPI), projects, including hardware and software products
  • Monitor supplier performance through the supplier management program.  Where necessary, work with suppliers to improve and sustain quality improvements
  • Qualify new suppliers and continually evaluate existing suppliers
  • Routinely compile and report key quality metrics data to multiple organizational levels
  • Serve as lead resource for Production Part Approval Process (PPAP)
  • Conduct technical investigations in support of the MDR process
  • Support Material Review Board (MRB) meetings to identify supplier quality issues and ensure timely disposition of nonconforming materials
  • Support Manufacturing Operations in efforts to drive process improvement and on time delivery
  • Lead internal audits of the QMS, as part of the Internal Audit Team

 

Minimum Qualifications:

  • BS in Engineering or similar discipline, preferably Electrical or Mechanical Engineering
  • 2 + years of quality engineering experience
  • 1+ years of experience in root cause analysis and implementing sustainable processes
  • 2+ years of experience in working within ISO/FDA compliant Quality Management Systems and supplier quality programs
  • Working knowledge of Process Controls and Design Controls within a regulated Quality Management System (CFR 820), and applicable knowledge of Risk Management and Supplier Quality.
  • Successful track record of driving continuous improvement in both quality and compliance.
  • Proficient with statistical software packages (preferably Minitab), as well as Microsoft Office. 

 

Preferred Qualifications:

  • Experience in Operations and/or Design Engineering highly desired.
  • Familiarity with electrical medical device manufacturing and the Toyota production business model helpful, but not required
  • 3+ years of experience in a medical device design and/or manufacturing environment or other regulated industry
  • Experience with root cause analysis, DOE, statistics, lean manufacturing, trending, Risk Management, and Six Sigma methodologies
  • 1+ years’ experience managing/leading projects

 

Why Kelly®?

Kelly puts you in charge of your career, with access to cutting edge projects and technologies in industry leading organizations. Top companies throughout the world have trusted Kelly as a premier source of engineering talent and services since 1965. And engineering job seekers know Kelly as a firm with an unmatched reputation for quality, integrity, and professionalism. Whether you seek the variety and flexibility of working on short-term project engagements or prefer contract-to-hire or direct-hire placement with our clients, apply with Kelly to explore opportunities that suit your specific professional interests.

About Kelly®

At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.

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