The role of the Site Quality Assurance Manager is to assist in managing the site quality management system and ensure that processes and procedures are developed in line with applicable standards and customer requirements. The Quality Assurance Manager will serve as a site leader in developing documents and tools to guide and improve the quality management system and serve as an educator to the existing operational personnel on quality management system requirements. The role will also support and assess the implementation of the Kenco Operating System as it relates to quality assurance.
Maintain, update, and add as necessary site policies, procedures, standard work instructions, and tools to improve the efficacy of the quality management system.
Administer internal audit program to ensure compliance to the quality management system through training auditors, auditing processes and procedures, and measuring results.
Identify training needs and organize training interventions to meet quality standards.
Investigate customer complaints and non-conformance issues and perform root cause and corrective action investigations to improve the quality management system.
· Collect and compile statistical quality data and analyze to identify areas for improvement to the quality management system.
A Bachelor’s degree in engineering, business, or related field required
Minimum of 5 years’ experience in a quality assurance role, regulatory affairs experience (FDA, DEA, etc.) desired.
Knowledge and experience with ISO 9001:2015
ASQ or other accredited certification as ISO lead auditor preferred
ASQ CSSGB preferred
Experience with ISO 13485 compliance and certification for Medical Devices
Preferred Experience with exporting medical devices to EU
Quality experience with Medical Device or Pharmaceutical
Manage and Develop QMS/EQMS
· Business Acumen - Knowledgeable in current and possible future policies, practices, trends, technology, and information affecting his/her business and organization
· Communicate for Impact - Devoting the time and resources necessary to communicate the strategic vision, direction, priorities, and progress of the team for which you are responsible
· Leading People - Ability to develop and implement strategies to maximize employee performance and foster employee engagement in meeting the organization's strategy
· Managing Transitions/ Change Management - Effectively plans, manages and communicates changes in processes with appropriate stakeholders
· Relationship Management - Building and maintaining relationships with internal partners to successfully complete projects and organizational objectives.
· Strategic Agility - Gains perspective and balances the pressure between daily tasks and strategic actions that impact the long-term viability of the organization.
This position is expected to travel approximately 25% or less.