This individual will report to the Quality Engineering Manager and is responsible for supporting the Material Sciences QMS Processes, Product Quality, and the nonconforming product process within the New Castle, Delaware Manufacturing facility. Responsibilities include leading investigations into product non-conformances, reporting quality system metrics, supporting product transfers into production, and driving improvement activities and projects related to product and process quality. Additional responsibilities include supporting Internal and External Audits and Findings. This includes driving improvement activities in these areas and collaborating on projects to harmonize activities across TA sites, Lead Material Review Board (MRB) and trending meetings. 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 Waters sites.
Responsibilities
• Responsible for ensuring compliance to ISO 9001 QMS Processes
• Support the ongoing development and maintenance of the QMS
• Identify areas of Improvement within the manufacturing and quality management system, and help drive improvements
• Maintain support QMS metrics
• Support maintainance of the Non-Conformance & Complaint systems
• Compile 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.
• Provide and report on key performance metrics
Qualifications
Qualified individuals should have a bachelor’s degree in engineering, Business, Mathematics, Science, or technical field.
Experience:
• Minimum 10 years of experience in Quality Assurance or related field.
• 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