Overview:
This individual is responsible for supporting the TA Instruments QMS Processes, Product Quality, and the nonconforming product process within the Lindon Utah Manufacturing facility. Responsibilities include leading investigations into product non-conformances, developing and reporting quality system metrics, supporting product transfers into production, and driving improvement activities and projects related to product and process quality. Additional responsibilities include hosting all Internal and External Audits and processing Findings. This includes driving improvement activities in these areas and collaborating on projects to harmonize activities across TA sites, chair of Material Review Board (MRB) and trending meeting. This position is hands-on in a fast-paced environment which will interact with multiple functions (R&D, Engineering, Operations, Test Engineering, Reliability Engineering, Regulatory, and Purchasing) and other TA manufacturing sites.
Responsibilities:
* Responsible for ensuring Full Compliance to ISO 9001 QMS Processes
* 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, supplier quality, and plant quality control"
* Identify areas of Improvement within the manufacturing and quality management system, and drive improvements for each area identified
* Responsible for Formulation, development, implementation, and management of metrics, procedures, and systems pertaining to Quality. Monitoring performance and driving improvements
* Manage and Maintain Internal and External Audit Processes
* 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
* Manage and Maintain Non-Conformance & Complaint systems
* Responsible for the maintenance, administration and compliance of the corrective/preventive action and non-conformance systems using sound root cause analysis tools
* Oversee the planning and execution of continuous improvement projects that drive focus on product and process quality.
* Manage Quality systems by compiling quality data, performing and supporting audits, reviewing non-conformances ensuring root cause analysis are completed.
* Review records, procedures, work instructions, forms etc. to ensure that they are accurate, complete and compliant with the process and with the requirements of the quality management system.
* Reporting key performance metrics for reporting and developing process improvements.
Qualifications:
Education:
Qualified individuals should have a bachelor's degree in engineering (Electrical Engineering, Chemical Engineering, Mechanical Engineer, etc.), Business, Mathematics, Science, or technical field with emphasis on statistical skills. Advanced degree preferred.
Experience:
* Minimum 10 years of experience in Quality Assurance or related field.
* Working knowledge of mechanical drawings (Geometric Dimensioning and Tolerancing - GD&T), along with electrical and fluidic schematics.
* Project management skills, exceptional organizational and time management skills, attention to detail, critical thinking and problem-solving skills, and commitment to client satisfaction are essential.
* Working experience and knowledge of quality management systems in ISO 9001
* Working experience and knowledge of Incoming Inspection
* Certified Lead Auditor in ISO 9001
* Proven track record of managing an effective CAPA process
* Analytical thinker and problem solver
* Ability to work independently across multiple organizations.
* Demonstrated implementation of continuous improvement methodologies
* Operational Excellence/Six Sigma/Lean training or certifications
* Experience supporting the manufacture of complex electromechanical/mechanical assemblies
* Experience using SAP or Oracle
* Good report writing and reviewing skills
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