Quality Service Engineer

Purpose: Responsible for imporoving customer experience through diligent focus on internal audits and supplier quality throughout the US Service business and supply chain. This position will report to the Service Quality Systems Manager and will participate in and lead continuous improvement efforts aimed at meeting customers’ quality, compliance, and cost expectations. This role is also responsible for supporting and maintaining the Service Quality Management System in compliance with the following standards and requirements: ISO9001, FDA’s Quality System Regulations 21CFR820, and ISO 13485. The role will also assist in transition from ISO 9001:2008 to ISO 9001:2015.

Main Responsibilities:

This position is responsible for advancing and strengthening the Service Internal Audit Program.

• Develop, coordinate, and execute internal audit plans and audits;
• Generate internal audit reports; audit corrective action requests on audit non-conformances.
• Provide support for corrective and preventative action processes.
• Diligently work with employees, contractors, and customers to proactively improve service quality; customer, contractor, and employee efficiency and satisfaction. Improve the customer experience.
• Provide Quality guidance and training to other employees.
• Participate in PKI Cross Site Audits; Customer Audits; 3^rd Party Audits

This position is responsible for advancing and strengthening the Supplier Quality Management Program.

• Audit / evaluate potential new suppliers;
• Advance, coordinate, and execute supplier qualification program;
• Develop, coordinate, and execute supplier quality audit plans and audits;
• Generate supplier audit reports; audit corrective action requests on audit non-conformances.
• Provide support for supplier corrective and preventative action processes.
• Diligently work with suppliers to improve the supplier quality relationship, supplier performance; implement process control, and quality plans.
• Disposition nonconforming materials and services, and manage Supplier Corrective Actions
• This position participates as a key team resource and representative aimed at success in all existing, potential, and future Quality Management programs and integrations with the business.