Quality Engineer II, Instrument Plant

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 statistical software packages
• First-hand audit experience (Preferred)
• Microbiology/molecular science background (Preferred)
• Data efficiency optimization (Preferred)

Preferred Qualifications

• Manual assembly manufacturing experience
• Experience with microbiological and chemical test methods