Quality Engineer II, Instrument Plant

Becton Dickinson; Maryland; On-site; USD 90,000 - 120,000; Full time

Job summary

Waters is seeking a Quality Engineer II to ensure compliance with plant and departmental procedures and regulatory requirements. You will apply advanced statistical tools to support multiple product lines within a regulated, high-volume testing environment.

The role emphasizes CTQ analysis, cross-functional collaboration, and hands-on problem solving from design through post-market stages, including CAPAs and change controls.

Qualifications

• Bachelor's degree in Biological Sciences, Chemistry, or Regulatory Affairs.
• At least 2 years' experience in Quality Assurance, Quality Control, or product/process non-conformance investigations.
• Experience in a medical device or pharmaceutical manufacturing facility.

Responsibilities

• Maintain ISO and regional regulatory requirements across the product lifecycle.
• Develop and maintain Device History Files in full regulatory compliance.
• Perform trend analysis, risk management, and Six Sigma tools for continuous improvement.

Skills

Quality Assurance

Statistical analysis

Risk management

Cross-functional teamwork

Documentation

Education

Bachelor's degree

Tools

SAP

Excel

PowerPoint

FMEA

Job description

As a result of the combination of the BD Biosciences and Diagnostic Solutions business with Waters Corporation (NYSE: WAT), by applying to this role, you will be applying for a position with Waters. Waters is a global leader in life sciences, dedicated to accelerating the benefits of pioneering science through analytical technologies, informatics, and service. With a focus on regulated, high-volume testing environments, Waters' innovative portfolio harnesses deep scientific expertise across biology, chemistry, and physics. Waters collaborates with analytical laboratories around the world to advance the release of effective, high-quality medicines, assure the safety of food and water, and drive better patient outcomes by detecting diseases earlier, managing routine infections, and combatting growing antibiotic resistance. Through a shared culture of relentless innovation, Waters' passionate team of approximately 16,000 colleagues partner with customers to turn scientific challenges into breakthroughs that improve lives worldwide.

We are the people who give possibilities purpose

BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities.

Job Description

As our Quality Engineer II, you'll be the go-to expert for applying and interpreting plant and department procedures, ensuring we stay consistent and compliant with our Quality Systems. You'll leverage sophisticated statistical and analytical tools while working across enterprise systems and corporate directives to support both new and existing product lines.

Responsibilities

• Champion Quality Compliance: Maintain International Organization for Standardization (ISO) and regional regulatory requirements across the entire product lifecycle - from design and manufacturing to assembly, testing, inspections, and customer complaint resolution
• Master Documentation: Develop and maintain Device History Files in full compliance with regulatory requirements, ensuring every detail is captured and accessible
• Drive Quality Intelligence: Generate critical CTQ (Critical to Quality) indices and provide actionable recommendations and solutions to emerging issues for project teams, operations, and suppliers
• Lead Product Integration: Support the seamless integration of new products into Manufacturing and Operations, ensuring quality is built in from day one
• Ensure Regulatory Excellence: Guarantee that BD Diagnostic Systems divisional and departmental policies, procedures, practices, and facilities meet all applicable regulatory requirements
• Mentor and Coach: Share your expertise by helping others understand and apply Quality Systems and procedures effectively
• Analyze and Optimize: Perform sophisticated trend analysis, risk management (including FMEA, Hazard Analysis, and Fault Tree analysis), and apply Six Sigma tools to drive continuous improvement
• Variety: Support one or more instrument platforms on sustaining activities including complaints, non-conformances, and daily operational challenges
• Leadership Opportunities: Take the lead on root cause investigations for moderately complex issues and make a tangible difference
• Cross-Functional Collaboration: Work closely with Research and Development, Operations, and other key departments - collaboration is part of your daily routine!
• Hands-On Problem Solving: Actively participate on teams, support audits, ensure documentation compliance, and process CAPAs, change controls, and deviation waivers
• Strategic Impact: Your work directly influences product quality and customer satisfaction across our entire portfolio

Education and Experience

• Bachelor's degree. Typical degrees in Biological Sciences, Chemistry, and/or Regulatory Affairs.
• 2 years' experience in Quality Assurance, Quality Control, or Product/Process non-conformance investigations
• Experience in a medical device or pharmaceutical manufacturing facility.
• SAP transaction experience.

Knowledge and Skills

• Multi-task management and change management plan execution
• Conflict management and results-driven performance with minimal supervision
• Team collaboration and cross-functional coordination
• FDA 21 CFR 820 regulations (moderate knowledge, ISO 9000:2000 and ISO 13485:2003 standards (moderate knowledge), GLP/GMP/ISO requirements and Quality System regulations
• Medical device regulations and regulated environment experience
• Design Control requirements
• Medical Device Validations (preferred)
• Data analysis using Six Sigma, root cause analysis, failure analysis, and risk assessment (moderate to difficult complexity)
• Statistical methods and tools application
• Risk management and risk-based decision making
• Proficiency in Excel, PowerPoint, and statistic