Senior Quality Engineer

2 weeks ago


Southaven, United States Cynet Systems Full time
Job Description:

Responsibilities:
  • Develop, implement, maintain and improve appropriate quality system elements to ensure a degree high product quality and continuous improvement.
  • Provide Quality Engineering support for, NPI, Sustaining activities and improvement projects.
  • Own and/or support Quality Notifications (Non-Conformance events), Correction and Preventive Actions (CAPA) as needed and assigned.
  • ssess Manufacturing and Design changes against their impact and support the implementation of such changes.
  • Support Post Market in the analysis of Complaint data and RMAs Failure Analysis investigation.
  • Collect, analyze, and trend product quality data and provide reports to management on progress or escalation.
  • uthor test protocols/reports (MVPs, IQ/OQ/PQ, Engineering reports) and execute qualification and validation testing as needed.
  • ddress product quality issues and approve material dispositions.
  • Support Internal and External audits.
  • Design and implement Quality System processes, procedures, and techniques such as risk assessment, root cause analysis, etc.
  • Interface with other engineering departments, manufacturing sites, customers, and suppliers on quality related issues in a timely manner.
  • pply knowledge of process control tools, statistical sampling and other analytical techniques to maximize the quality and flow of product through the production line.
  • Identify, analyze, and manage risk through product life cycle with use of risk management tools.
  • Troubleshoot equipment, process or material issues and provide resolutions.
  • Support projects to support the site manufacturing and quality improvement initiatives.
  • Performs other duties assigned as needed.
Qualifications:
Skills Experience Education And Training:
  • Minimum Education: 4-year degree in STEM. Engineering degrees are preferred.
  • 6 years of related work experience in a regulated industry or a minimum 4 years with a master's degree.
  • Preference for Electro-Mechanical Medical Device experience.
  • Experience in Quality, Manufacturing, or Research and Development experience in a medical device or other regulated industry.
  • bility to define problems, collect and analyze data, establish facts, and draw conclusions and recommendations (i.e., Root Cause Problem Solving).
  • bility to apply project management skills to ensure fulfillment of new product development requirements.
  • bility to develop and implement Quality standards.
  • Demonstrated auditing and problem-solving skills.
  • Strong knowledge of Quality Engineering, design control, and verification and validation (V&V) tools and methodologies.
  • bility to effectively communicate with internal and external personnel at all levels of the organization.
  • Well-developed influencing and negotiation skills.
  • bility to effectively train and mentor a diverse array of employees at all levels of the organization.
  • Strong understanding of Six Sigma and Process Excellence tools and methodologies.


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