Sr Testing and Quality Engineer

tacareers-waters; New Castle (DE); On-site; USD 110,000 - 160,000; Full time

Job summary

Waters Corporation in New Castle, Delaware seeks a senior quality professional to support the Material Sciences QMS, product quality, and nonconforming product processes at the New Castle facility. Responsibilities include leading investigations, audits, CAPA, and driving Continuous Improvement; collaborate across R&D, Engineering, Operations, and Regulatory to harmonize activities across Waters sites.

The role emphasizes hands-on leadership in a fast-paced environment with strong ISO 9001/17025

Qualifications

• Bachelor’s degree in engineering, business, science, or technical field.
• At least 10 years in Quality Assurance or related field.
• Experience with ISO 9001 and 17025; Lead Auditor certification preferred.
• Proven CAPA and problem-solving skills.
• Experience with SAP or Oracle is a plus.

Responsibilities

• Ensure compliance to ISO 9001 QMS Processes.
• Develop and maintain the QMS.
• Identify areas of improvement within manufacturing and QMS.
• Maintain QMS metrics.
• Support Non-Conformance & Complaint systems.
• Compile quality data and support audits and root cause analysis.

Skills

Quality Assurance

ISO 9001

CAPA process

Lead Auditor

17025 experience

Project management

Six Sigma

SAP or Oracle

Analytical thinking

Independent collaboration

Education

Bachelor's degree (Engineering, Business, Science)

Tools

SAP

Oracle

Job description

Overview

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.

Typical tasks of the position include, but are not limited to

• 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

The successful candidate will have a combination of knowledge, skills, and experience that would include the following

Qualified individuals should have a bachelor’s degree in engineering, Business, Mathematics, Science, or technical field.

Experience:

• Minimum10 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
• Must have 17025 experience
• 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

Company Description

Waters Corporation (NYSE:WAT)is a global leader in life sciences and diagnostics, dedicated to accelerating the benefits of pioneering science through analytical technologies, informatics, and service. With a focus on regulated, high-volume testing environments, our innovative portfolio harnesses deep scientific expertise across chemistry, physics, and biology. We collaborate with customers around the world to advance the release of effective, high-quality medicines, ensure the safety of food and water, and drive better patient outcomes by detecting diseases earlier, managing routine infections, and combating antibiotic resistance. Through a shared culture of relentless innovation, our passionate team of ~16,000 colleagues turn scientific challenges into breakthroughs that improve lives worldwide.

Diversity and inclusion are fundamental to our core values at Waters Corporation. It benefits our employees, our products, our customers and our community. Waters 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.