Quality Engineer II; Instrument Plant

Job Description Summary

The Quality Engineer II is responsible for the application and interpretation of plant/department procedures to ensure consistency/compliance with Quality Systems. Utilizes the Company Quality Systems to ensure overall compliance and applies appropriate statistical and analytical tools. Works with enterprise systems and Corporate directives to support current and future product lines and processes. Typical assignments include supporting instrument platforms on sustaining items such as complaints, non‑conformances and day‑to‑day issues, supporting audits, actively participating on teams, ensuring documentation compliance, processing CAPAs, change controls, and deviation waivers.

Frequently interacts with research and development, operations and other functional areas. May lead root‑cause investigations for issues of moderate complexity.

BD is one of the largest global medical technology companies. Advancing the world of health™ is our Purpose. We believe the human element across our global teams allows us to continually evolve.

• Maintain ISO and regional regulatory requirements, focusing on quality for product design, manufacturing, inspections, and customer complaints throughout the product life cycle.
• Develop and maintain Device History Files in accordance with regulatory requirements.
• Generate process/product quality information (CTQ indices, recommendations, solutions) and share with project team, operations, and suppliers.
• Support the integration of new products into manufacturing and operations.
• Ensure BD Diagnostic Systems divisional and departmental policies, procedures, and practices comply with all applicable regulatory standards.
• Understand and coach others on Quality Systems and procedures.
• Perform trend analysis, risk management (FMEA, Hazard Analysis, Fault Tree) and six‑sigma tools.
• Work in a team environment, manage multiple tasks, resolve conflicts and drive results with minimal supervision.
• Apply knowledge of GLP/GMP/ISO requirements and relevant Quality System regulations.
• Use word processing, spreadsheets, and a statistical package etc.
• Analyze data using systematic analytical tools such as Six Sigma, root‑cause analysis, failure analysis and risk assessment.

• Bachelor’s degree in Biological Sciences, Chemistry, or Regulatory Affairs (other fields acceptable with appropriate experience; advanced degrees can substitute for experience).
• Minimum 2+ years’ experience in Quality Assurance, Quality Control, or product/process non‑conformance investigations.
• Experience in a medical device or pharmaceutical manufacturing facility.
• Experience with SAP transactions.
• Ability to manage multiple tasks and execute change‑management plans.
• Knowledge of FDA 21 CFR 820 and ISO 9000/13485 regulations.

• Familiarity with supplier management (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 process improvement background;
  • Meeting deadlines, achieving effective solutions
  • Validation involvement – quality advisor/approver
• Familiarity with medical device regulations and a regulated environment;
  • Preferable first‑hand audit experience
  • Preferable familiarity with manual assembly manufacturing
  • Preferable familiarity/background in microbiology/molecular science
• Complaint investigation/PMS activities.
• Data analysis and efficiency;
  • Effective use of Excel / PowerPoint and other tools to collect/analyze information

For most roles, a minimum of 4 days of in‑office presence per week is required. Remote or field‑based positions may have different arrangements. Certain roles require proof of full COVID‑19 vaccination.

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, sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally‑protected characteristics.

$73,300.00 – $ USD Annual