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Senior Quality Engineer

New Castle, DE 19720-

Posted: 02/25/2022 Employment Type: Direct Hire Category: Engineering Job Number: 61607 Pay Rate: 120,000

Job Description

Overview

This individual is responsible for supporting the QMS Processes and the nonconforming product process within the New Castle Manufacturing facility. Responsibilities include leading investigations into product non-conformances, developing and reporting quality system metrics, supporting product transfers into production, and driving improvement activities and projects related to product and process quality. Additional responsibilities include preparing for Internal and External Audits, and processing audit Findings. This includes driving improvement activities in these areas and collaborating on projects to harmonize activities across sites, chair of Material Review Board (MRB) and trending meeting. This position is hands-on in a fast-paced environment which will interact with multiple functions (R&D, Engineering, Test Engineering, Reliability Engineering, Regulatory, and Purchasing) and other manufacturing sites.

Responsibilities 
  • Manage and Maintain Internal and External Audit Processes
  • Manage and Maintain Non-Conformance systems
  • Manage Quality systems by compiling quality data, performing and supporting audits, reviewing non-conformances ensuring root cause analysis are completed
  • Review records, procedures, work instructions, forms etc. to ensure that they are accurate, complete and compliant with the process and with the requirements of the quality management system
  • Reporting key performance metrics for reporting and developing process improvements
Qualifications
  • Qualified individual should have a bachelor’ s degree in engineering (Electrical Engineering, Chemical Engineering, Mechanical Engineer, etc.), Business, Mathematics, Science, or technical field with emphasis on statistical skills.   Advanced degree preferred.
  • Minimum 5 years of experience in Quality Assurance or related field
  • Excellent communication skills, report writing and reviewing skills
  • Working knowledge of mechanical drawings (Geometric Dimensioning and Tolerancing - GD&T), along with electrical and fluidic schematics
  • Project management skills, exceptional organizational and time management skills, attention to detail, critical thinking and problem-solving skills, and commitment to client satisfaction are essential
  • Working experience and knowledge of quality management systems in ISO9001 or ISO13485
  • Analytical thinker and problem solver
  • Experience using Sparta Trackwise or other electronic QMS systems
  • Ability to work independently across multiple organizations
  • Demonstrated implementation of continuous improvement methodologies
  • ISO9001 or ISO13485 / cGMP knowledge base
  • Operational Excellence/Six Sigma/Lean training or certifications
  • Experience using Smartsheets and Power BI
  • Experience in a electromechanical manufacturing facility
  • Experience using Smartsheets, Power BI
  • Experience using SAP or Oracle
  • Experience supporting the manufacture of complex electromechanical assemblies 
  • Good report writing and reviewing skills
  • Knowledge of various quality systems
  DAVIS Companies partners with the top employers locally and nationally. They choose us because of our reputation for finding high quality talent, fast, but also our experience for evaluating and representing the best candidates in the marketplace.   We make every effort to provide updates and feedback to candidates at each stage of the process as we appreciate how stressful looking for a new role can be.   Apply today and experience “ The DAVIS Difference”. 
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As an Equal Employment Opportunity Employer, DAVIS has reporting requirements which require us to invite employees to voluntarily self-identify their race/ethnicity. Submission of this information is voluntary and refusal to provided it will not subject you to any adverse treatment. The information obtained will be kept confidential.