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Sr Quality Engineer

3 months ago


Southaven, United States Vakulatech Full time
Job DescriptionJob DescriptionPlease Share your resume to jobs@vakulatech.comJob Role: Sr Quality EngineerLocation: Southaven, MississippiContract: W2Job Roles and Responsibilities:
  • Ensure that manufacturing processes comply with quality standards performing follow-ups and monitoring the Notifications generated, process validations, post market complaint analysis and defect trends, in accordance with international industry practices and regulations (ISO 13485, 21CFR820); to meet the objectives of the quality department, providing support in corrective and preventive actions (CAPAS) and implementing actions that generate defect reduction.
  • 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.
  • Assess 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.
  • Author test protocols/reports (MVPs, IQ/OQ/PQ, Engineering reports) and execute qualification and validation testing as needed.
  • Address 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
QualificationsSkills, Experience, Education, & 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.
  • Ability to define problems, collect and analyze data, establish facts, and draw conclusions and recommendations (i.e., Root Cause Problem Solving).
  • Ability to apply project management skills to ensure fulfillment of new product development requirements.
  • Ability 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.
  • Ability to effectively communicate with internal and external personnel at all levels of the organization.
  • Well-developed influencing and negotiation skills.
  • Ability 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.