Lead Quality Engineer

  • Full Time
  • Portland, ME
  • This position has been filled

Our client is a growing/scaling startup medical device OEM, building a top notch quality team. As the lead Quality Manager or engineer, you will oversee and manage their quality program, including ISO certifications and ensure products produced meet customer expectations. The right candidate will serve on the leadership team and share in their commitment to safety, quality, productivity and regulatory compliance.

Quality Management:

  • Engage and interact with company teams to bridge/resolve customer expectations and drive a quality focused company
  • Establish and maintain Quality Management processes and procedures. Ensure accurate documentation and statistical analysis on quality related issues.
  • Lead and manage the QA team; train, coach, and develop a collaborative approach in their dealings with each other and with peers, colleagues, customers and suppliers. Facilitate the development of long-range goals and objectives for quality team direct reports and deliver meaningful individual performance guidelines.
  • Lead Quality Management Reviews and Internal Audits, deploy quality improvement strategies and initiatives, identify and share best practices, lead cross-functional focused improvement teams and report to top management on the effectiveness of the Quality Management System.
  • Lead root cause analysis of non-conformance, corrective actions, initiate follows-up, and cost-effective resolutions; this includes quality process improvements (scrap reduction, rework reduction, due to process, product, material and service, etc.).
  • Oversee document management system, company quality control guidelines and procedures, other controlled policies and procedures, instructions, forms, and records.
  • Analyze and interpret quality data, conduct research on product defects and recommend modifications in processes, products or quality standards to eliminate waste.
  • Oversee implementation of measurement tools that enable effective evaluation. Track, and report on quality measurement systems and Key Performance Indicators.
  • Solicit feedback from customers to assess whether their requirements are met.
  • Understand customer needs/requirements to develop effective quality control processes to promote a quality driven culture
  • Stay abreast of the latest quality management best practices and concepts


  • BS/BA degree technical discipline preferred and quality or process engineering experience in a manufacturing environment.
  • Statistical methods & process improvement techniques
  • Excellent mathematical & statistical ability
  • Familiarity with the MEP/MRP/ERP software a plus