Quality Engineer

MACK Electronics   •  

Westford, MA

Industry: Pharmaceuticals & Biotech

  •  

5 - 7 years

Posted 169 days ago

This job is no longer available.

Quality Engineer

Summary

The Quality Engineer is responsible for sustaining and improving process, product, and supplier performance. The individual will develop quality plans, manage supply base performance, and drive deep corrective/preventive action analysis and implementation. The Quality Engineer will also provide engineering support in procedural development and change order analysis.

Essential Duties and Responsibilities

  • Lead quality teams in an effort to drive high product quality and continuous improvement and increased customer satisfaction
  • Manage, analyze and publish Quality Assurance Performance Reports for assigned projects including process yields, defect / root cause pareto analyses, and associated corrective actions
  • Analyze process, product, and component performances to identify continuous improvement opportunities
  • Develop and manage customer specific quality plans
  • Develop and issue PFMEAs
  • Provide weekly Management level reports and analysis on customer and process level Quality data and information
  • Provide technical assistance on customer product specifications such as labels, quality goals, assembly requirements and product performance criteria
  • Participate in establishing ISO 9001, ISO13485, and AS9100 internal controls and procedures
  • Review quality and product data to ensure conformance to specifications
  • Generate and drive corrective action on CARs
  • Perform Internal Quality Audits
  • Lead failure analysis efforts on systemic non-conformances and field returns and then implement appropriate corrective actions
  • Generate procedures, process alerts, deviations, purges, and other process documentation
  • Lead the MRB review and disposition process
  • Provide NPI support to the product team, suppliers, and customers
  • Other responsibilities as directed and necessary for the business


Qualifications

  • BS Degree in electrical, mechanical or industrial engineering or equivalent experience
  • 5+ years in quality, process, and/or supplier engineering in a manufacturing environment
  • ISO auditor certification desired
  • Knowledge of statistics and statistical methods
  • Experience in vendor certification and process qualification
  • Background in a medium to high volume system level, assembly, and/or SMT manufacturing environment including electrical, mechanical, and/or PCA components
  • 6 Sigma Green or Black Belt desirable
  • ASQ CQE desirable