Senior Quality System Engineer

Hopkinton MA US Shelton CT US
Sep 22, 2016
Feb 27, 2017
Organization Type
Full Time
The Quality Systems Engineer (Customer Feedback) facilitates business unit and site level customer complaints process in order to ensure appropriate remedy of product quality and service issues in a timely manner. This will include the development and implementation of information systems and reporting processes to ensure appropriate prioritization of issues based upon risk to the customer and business; leading to resolution through CAPA, recall, or field actions. This role is also responsible for supporting and maintaining the sites Quality Management System in compliance with ISO9001 and ISO 13485.

Key Responsibilities
  • Develop and improve customer complaints handling system at business unit and site levels to facilitate rapid identification, resolution and feedback loops of all customer and field issues in order to meet customer and product quality objectives.
  • Ensure the adequacy of Quality Management System procedures to support the complaint handling program; this will include working closely with the field service, customer care and technical support organizations to ensure that field and customer data is entered promptly and accurately into the complaints handling system.
  • Work with divisional IT and service organizations towards collecting and analyzing data from various databases, trend the data and identify key opportunities for improvement.
  • Generate and evaluate customer complaint related metrics, establish appropriate baselines and demonstrate continuous improvement results; support business unit objectives through reduction of complaints and improving first time right performance.
  • Interface directly with field service, technical support and sales personnel to ensure alignment of complaint data, warranty cost data and technical support calls with customers and service engineers.
  • Support global review of complaints and service costs and service metrics; lead the review by a cross functional team, prioritization and appropriate escalation to corrective and preventive action requests (CAPA).
  • Apply statistical techniques, risk assessments, causal analysis, as needed.
  • Act in the role of CAPA owner when assigned and lead teams through structured problems solving and other phases of the CAPA process.
  • Support and/or facilitate recalls and field corrective actions according to corporate procedure.
  • Conduct necessary training to ensure that the customer complaints databases are being utilized and populated appropriately.
  • Review PKI Customer Feedback and Complaint handling related procedures to ensure compliance with ISO 9001/13485 system and participate in internal/External ISO audit of the complaints handling processes.