Quality Engineer II; Instrument Plant

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 Med Tech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

The Quality Engineer II is responsible for applying and interpreting plant/department procedures to ensure consistency and compliance with the Quality Systems. The Engineer uses the Company Quality Systems to ensure overall compliance and has the knowledge necessary to apply the appropriate statistical and analytical tools. The role supports one or more instrument platforms on sustaining items such as complaints, non-conformances, day-to-day issues, audits, documentation compliance, CAPA processing, change controls, and deviation waivers.

The Engineer often takes the lead on root cause investigations for issues of moderate complexity and works closely with Research and Development, Operations, and other functional areas.

• Maintain International Organization for Standardization (ISO) and regional regulatory requirements. Key elements focus on multiple aspects of quality for product design, manufacturing (assembly and test), inspections and customer complaints throughout the product life cycle.
• Develop Device History Files and maintain them in a manner consistent with regulatory requirements.
• Generate process/product quality information in the form of CTQ (Critical to Quality) indices, recommendations and solutions to emerging issues, to share with the project team, operations and suppliers.
• Supports the coordinated integration of new products into Manufacturing/Operations.
• Ensures BD Diagnostic Systems divisional, departmental policies, procedures, practices and facilities are in compliance with all applicable regulatory policies.
• Understanding and coaching others on Quality Systems and procedures.
• Perform trend analysis, risk management (such as FMEA, Hazard Analysis, Fault Tree) and Six Sigma tools.
• Cost Center Specific:
• Skilled in working in a team environment, ability to perform multiple tasks, effectively manage conflict and drive for results with minimal supervision.
• Knowledge of GLP/GMP/ISO requirements and sound understanding of the pertinent Quality System/Regulations.
• Computer skills in word processing, spreadsheets and a statistical package required. Must have excellent communication skills.
• Knowledge of manufacturing processes, use of statistical tools required, and knowledge of microbiological and chemical test methods are preferred.
• Experience using statistical methods is required. Familiarity with Design Control requirements and knowledge of Medical Device Validations is preferred.

• Bachelor's degree. Typical degrees in Biological Sciences, Chemistry, and/or Regulatory Affairs. Other fields can be considered with the appropriate experience to support the role. An advanced degree can make up for experience requirement.
• 2+ years’ experience in Quality Assurance, Quality Control, or Product/Process non-conformance investigations.
• Experience in a medical device or pharmaceutical manufacturing facility.
• Ability and skill to effectively manage multiple tasks and drive execution of change management plans.
• SAP transaction experience.
• Ability and skill to analyze data using systematic analytical tools such as Six Sigma, root cause analysis, failure analysis and risk assessment to gather critical information that has moderate to difficult complexity.
• Moderate knowledge and understanding of the Food and Drug Administration (FDA) 21 CFR 820 and International Organization for Standardization (ISO) ISO 9000:2000 and ISO 13485:2003.

• Familiarity with supplier management, especially SCARs and driving change
  • Preferable contract manufacturing familiarity
• Risk management and risk-based decision making
  • Familiarity with DHF, DMR, HA, pFMEA, dFMEA, RMP/RMR/BRA
  • Risk as part of design change - standing up for quality
• CAPA and/or process improvement…