Quality Engineer

Job Description:  We are seeking a highly-motivated individual to join our product
commercialization team to champion the development and implementation of company-wide quality methods and best practices within a dynamic start-up environment.

Position:  Full-time.  Reports to Director of Manufacturing and Supply Chain.

Location:  Cincinnati, Ohio, USA

Duties Include: 

  • Lead efforts to establish quality operations within a rapidly growing start-up, including development of quality processes, quality assurance documentation, quality control measures and implementation of overall Quality Management System (QMS)
  • Adapt quickly within a dynamic start-up environment, with focus on implementing quality measures ranging from upstream supply chain, to internal operations, to downstream customers
  • Improve product quality, reliability and customer satisfaction by investigating product field failures and conducting root cause and trend analysis
  • Ensure timely, accurate, and complete failure investigations and root cause analyses through the use of QA tools (Six Sigma, 5 Whys, root cause analyses, etc.), and document findings
  • Perform QC spot checks to validate product against expected configuration and performance
  • Organize/lead cross-functional teams to help identify problem issue(s) and drive product improvement
  • Perform and document failure investigations for customer complaints leading to the identification of root cause and potential corrective/preventive actions. Ensure timely closure of complaints to comply with FDA and other regulatory requirements. Perform reliability analysis to identify and address negative trends
  • Establish, maintain and continually organize Quality Management System database for audit readiness
  • Deploy strong design and manufacturing practices knowledge to make recommendations to prevent future failures
  • Creatively utilize Lean, Six Sigma and other continuous improvement methods to aid in the standardization, reliability, improvement and optimization of production and business processes
  • Support the resolution of field issues and work with R&D, Product Development, Operations, Manufacturing, Sales, Marketing and Business Development departments to resolve issues
  • Ensure timely, accurate and complete failure investigations of product complaints leading to root cause and corrective/preventive action
  • Lead product complaint reviews by presenting complaint trends and recommendations for corrective action and product improvement to relevant stakeholders

Preferred Qualifications and Skills:

  • Bachelor’s degree in Engineering discipline; MBA or MS a plus.
  • Experience as a Reliability Engineer, Quality Engineer, or relevant role conducting failure investigations, continuous improvement and/or performing failure analysis
  • Demonstrated applied knowledge of advanced reliability tools such as Failure Modes Effect Analysis (FMEA), reliability testing, statistical techniques
  • ASQ and other quality-related certifications; Six Sigma Black Belt preferred
  • Demonstrated ability to effectively work cross-functionally with other departments including, Regulatory Affairs, R&D, Product Development, Operations, Manufacturing, Sales, Marketing and Business Development
  • Demonstrated interpersonal and communication skills
  • Demonstrated ability to exhibit a positive, energetic approach to teamwork
  • Demonstrated ability to advocate for product excellence and quality
  • Knowledge and experience with implementing and maintaining certification of FDA and international medical device regulations/standards/directives (ISO 9001, ISO 13485, ISO 14971, 21CFR820, 93/42/CE, cGMPs)

If interested in this position, please apply below.  All inquiries are handled confidentially.

Eccrine Systems, Inc., is an equal opportunity employer. Qualified applicants will be considered without regard to age, race, creed, color, national origin, ancestry, marital status, affectional or sexual orientation, gender identity or expression, disability, nationality, sex, religion, or veteran status.