Sr Testing and Quality Engineer
Listed on 2026-06-26
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Quality Assurance - QA/QC
Regulatory Compliance Specialist, Quality Engineering, Production QC/QA, Quality Control - QC Analysts/Managers -
Engineering
Regulatory Compliance Specialist, Quality Engineering
Overview
In this role you will report to the Quality Engineering Manager and play a key part in supporting the Material Sciences QMS Processes, Product Quality, and the nonconforming product process at the New Castle, Delaware Manufacturing facility. You will lead investigations into product non‑conformances, report quality system metrics, support product transfers into production, and drive improvement activities and projects that enhance product and process quality.
Additional duties include supporting internal and external audits and findings, driving improvement across TA sites, the Lead Material Review Board (MRB) and trending meetings, and collaborating with multiple functions such as R&D, Engineering, Operations, Test Engineering, Reliability Engineering, Regulatory, and Purchasing as well as other Waters sites.
- Ensure compliance with 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 QMS metrics.
- Support the maintenance of the Non‑Conformance & Complaint systems.
- Compile quality data, perform and support audits, review non‑conformances ensuring root cause analysis is completed.
- Review records, procedures, work instructions, forms, etc. to ensure they are accurate, complete and compliant with the process and the requirements of the quality management system.
- Provide and report on key performance metrics.
- Bachelor’s degree in engineering, Business, Mathematics, Science, or a technical field.
- Minimum 10 years of experience in Quality Assurance or a related field.
- Project management skills, exceptional organizational and time‑management skills, attention to detail, critical thinking and problem‑solving skills, and a commitment to client satisfaction.
- Experience and knowledge of ISO 9001 quality management systems.
- 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 manufacturing of complex electromechanical/mechanical assemblies.
- Experience using SAP or Oracle.
- Good report writing and reviewing skills.
Waters Corporation complies with all applicable federal, state, and local laws. Qualified applicants are considered without regard to sex, race, color, ancestry, national origin, citizenship status, religion, age, marital status (including civil unions), military service, veteran status, pregnancy (including childbirth and related medical conditions), genetic information, sexual orientation, gender identity, legally recognized disability, domestic violence victim status, or any other characteristic protected by law.
Waters is proud to be an equal‑opportunity workplace and is an affirmative action employer. All hiring decisions are based solely on qualifications, merit, and business needs at the time.
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