Quality Engineer II - Instrument Plant

Job Description

As the Quality Engineer II, you will be the go-to expert for applying and interpreting plant and department procedures, ensuring consistency and compliance with our Quality Systems. You will leverage statistical and analytical tools while working across enterprise systems and corporate directives to support new and existing product lines.

• 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 indices and provide actionable recommendations and solutions for emerging issues to 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 expertise by helping 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 Instrument Platforms:
  Handle sustaining activities including complaints, non-conformances, and daily operational challenges on one or more instrument platforms.
• Root Cause Leadership:
  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 as part of daily routine.
• Hands-On Problem Solving:
  Participate in audit teams, ensure documentation compliance, and process CAPAs, change controls, and deviation waivers.
• Strategic Impact:
  Directly influence product quality and customer satisfaction across the entire portfolio.

• Bachelor's degree; typical fields include Biological Sciences, Chemistry, and/or Regulatory Affairs.
• Minimum of 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.

• 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, and GLP/GMP/ISO requirements.
• Experience with medical device regulations and regulated environments.
• Understanding of Design Control requirements.
• Preferred:
  Medical Device Validations.
• Data analysis using Six Sigma, root cause analysis, failure analysis, and risk assessment.
• Statistical methods and tool application.
• Risk management and risk-based decision making.
• 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.
• Knowledge of microbiological and chemical test methods.

We prioritize on‑site collaboration: a minimum of 4 days of in‑office presence per week is required for most roles, though flexibility is considered on a case‑by‑case basis. Remote or field‑based positions may have different arrangements. For certain roles, employment is contingent upon the company’s receipt of sufficient proof of full vaccination against COVID‑19. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

Primary

Work Location:

USA, MD – Sparks – 7 Loveton Circle.

We are an Equal Opportunity Employer and 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.

$75,800.00 – $ USD Annual