Overview:
The TA Quality Assurance Lead, working under the direction and supervision of the Senior Director Global Quality and Global Operations, leads a team of quality professionals focused on the planning and execution of projects and activities for all TA Instruments facilities to improve product and process quality, and analyze quality data (complaints, process non-conformances, process capability, etc.). The TA Quality Assurance Lead will also be a key resource in identifying and implementing best practices for process improvement, problem solving, and driving customer satisfaction. The successful candidate will possess strong leadership experience as it pertains to the development of high-performance quality assurance groups.
Responsibilities:
* Establish quality-led strategic initiatives and ensure execution of company objectives while adhering to regulatory requirements
* Develop, implement, and monitor quality system solutions to promote the highest levels of product quality and customer satisfaction and in accordance with regulatory compliance requirements
* Serve as a key resource in identifying and implementing best practices for process improvement, problem solving, and superior customer satisfaction
* Serve as Management System Representative
* Oversee, manage, and direct activities that support the ongoing development and maintenance of the QMS including change management, document control, CAPA, internal audits, external audits, validations, nonconforming product, deviations, training, management review, supplier quality, and plant clearance quality control
* Lead adherence and conformance to established quality assurance processes as well as relevant regularity accreditations and ISO certifications across all business divisions. Provide guidance and ensure compliance with applicable good documentation practice regulations, and company standards
* Develop and implement critical quality performance metrics focused on tracking and improving product and process quality. Support critical metrics, where applicable. Communicate results and provide routine feedback to leadership and executive management at all sites. Monitor performance and drive improvements
* Responsible for the maintenance, administration and compliance of the corrective/preventive action and non-conformance systems using sound root cause analysis tools
* Manage the internal audit process by ensuring efficient and effective auditing and quality management system to ISO-9001, and all applicable regulatory and industry standards including investigation and resolution of internal audit issues
* Oversee the planning and execution of continuous improvement projects that drive focus on product and process quality
* Lead, Coach, and Mentor Team
Qualifications:
Education:
Qualified individual should have at a minimum, a Bachelor's degree in Engineering (Electrical Engineering, Chemical Engineering, Mechanical Engineer, etc.), or Science with emphasis on statistical skills. Advanced degree preferred.
Experience:
* Minimum 10 years of experience in Quality Assurance or related field in a regulated industry
* Minimum 5 years of leadership experience, implementing and maintaining a Quality Management System (QMS) within an ISO registered environment. Experience and Knowledge of ISO 9001 and 17025 required
* Certified Lead Auditor in ISO 9001 required
* Essential Skills: Project management, exceptional organizational and time management, attention to detail, critical thinking and problem-solving, and commitment to client satisfaction
* Direct experience supporting and/or leading third-party audits (ISO registrars, FDA or other regulatory authorities)
* Strong leadership experience, excellent communication, and interpersonal skills
* Demonstrated project management and Operational experience, certifications preferred (Black Belt, Green Belt, Certified Associate in Project Management (CAPM), Project Management Professional (PMP), etc.)
* Analytical Thinker and Problem Solver
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