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Statistical Sampling Specialist

Job in Bethlehem, Northampton County, Pennsylvania, 18017, USA
Listing for: B. BRAUN MEDICAL (US) INC
Full Time position
Listed on 2026-08-25
Job specializations:
  • Quality Assurance - QA/QC
    Quality Engineering, Regulatory Compliance Specialist
Salary/Wage Range or Industry Benchmark: 92215 - 115271 USD Yearly USD 92215.00 115271.00 YEAR
Job Description & How to Apply Below

Risk And Reliability Statistical Specialist

We are seeking a Risk and Reliability Statistical Specialist to drive data-driven decision-making across quality, manufacturing, and risk management. This role applies statistical methods to improve product reliability, optimize sampling strategies, and ensure compliance within a regulated environment.

Key Responsibilities
  • Apply statistical methods for risk management (ISO 14971), including failure rates and probability analysis
  • Develop sampling plans for inspection, validation, and process monitoring
  • Perform reliability analysis (Weibull, lognormal, exponential)
  • Support process capability, trend analysis, and variation reduction
  • Lead/support CAPA investigations using data-driven approaches
  • Establish control limits and monitoring strategies
  • Remote role with up to 15% travel
Qualifications
  • Bachelor's in Engineering, Statistics, or related technical field
  • 5+ years in a regulated manufacturing environment (medical device, pharma, life sciences, healthcare)
  • Experience with statistical analysis, sampling, and reliability testing
  • Knowledge of ISO 13485, ISO 14971, FDA 21 CFR 820
  • Strong analytical, communication, and problem-solving skills required
Preferred
  • Advanced degree or training in Statistics/Reliability
  • Experience designing statistically justified validation and verification strategies
  • Six Sigma, CQE, or Reliability certification
Additional Info
  • Other Duties:
    Responsibilities may change based on business needs.
  • Physical Demands:
    Light work (up to 20 lbs occasionally). Primarily seated with occasional standing, walking, and reaching
  • Work Environment:
    Office setting; moderate noise.

Pay Range- $92,215 - $115,271 /annually

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