Quality Engineer II - Instrument Plant

As a result of the combination of the BD Biosciences and Diagnostic Solutions business with Waters Corporation, 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.

• Champion Quality Compliance:
  Maintain 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 for 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.
• Guarantee Regulatory Excellence:
  Confirm BD Diagnostic Systems divisional and departmental policies, procedures, practices, and facilities meet all applicable regulatory requirements.
• Mentor and Coach:
  Share expertise to help others understand and apply Quality Systems and procedures effectively.
• Analyze and Optimize:
  Perform trend analysis, risk management (including FMEA, Hazard Analysis, and Fault Tree analysis), and apply Six Sigma tools to drive continuous improvement.
• Support Sustaining
  
  Activities:
  
  Work on one or more instrument platforms covering complaints, non‑conformances, and daily operational challenges.
• Lead Root‑Cause Investigations:
  Take the lead on moderately complex issues and make a tangible difference.
• Collaborate Cross‑Functionally:
  Work closely with Research and Development, Operations, and other key departments.
• Hands‑On Problem Solving:
  Participate in audits, documentation compliance, and process CAPAs, change controls, and deviation waivers.
• Strategic Impact:
  Influence product quality and customer satisfaction across the entire portfolio.

• Bachelor’s degree in Biological Sciences, Chemistry, or Regulatory Affairs.
• At least 2 years of experience in Quality Assurance, Quality Control, or Product/Process non‑conformance investigations.
• Experience in a medical device or pharmaceutical manufacturing facility.
• SAP transaction experience.

• Multi‑task and change‑management plan execution.
• Conflict management and results‑driven performance with minimal supervision.
• Team collaboration and cross‑functional coordination.
• Moderate knowledge of FDA 21 CFR 820 regulations, ISO 9000:2000 and ISO 13485:2003 standards.
• GLP/GMP/ISO requirements and Quality System regulations.
• Knowledge of medical device regulations and regulated environments.
• Design Control requirements.
• Medical Device Validation (preferred).
• Data analysis using Six Sigma, root‑cause analysis, failure analysis, and risk assessment (moderate to difficult complexity).
• Statistical methods and tools application.
• Proficiency in Excel, PowerPoint, and statistical software packages.
• Word processing and spreadsheet expertise.
• First‑hand audit experience (preferred).
• Microbiology/molecular science background (preferred).
• Data efficiency optimization (preferred).

• Manual assembly manufacturing experience.
• Microbiological and chemical test methods.

Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.