Senior Quality Engineer

Responsibilities

• Drive Quality Excellence:
  Apply advanced technical principles, quality sciences, and proven methodologies to ensure our medical devices exceed industry standards and regulatory expectations.
• Solve Complex Challenges:
  Leverage your proven problem-solving skills to tackle quality issues head‑on, creating measurable improvements to BD’s processes and procedures that enhance efficiency and effectiveness.
• Champion Regulatory Compliance:
  Ensure every design control and production/process control project meets all applicable local and international regulatory requirements, plus Corporate and Unit standards.
• Collaborate Cross‑Functionally:
  Serve as the Quality representative on dynamic new product development and sustaining engineering teams, bringing your expertise to multidisciplinary projects.
• Exercise Approval Authority:
  Review and provide Quality Engineering approval for new and modified design/process specifications, including product performance specs, test methods, and critical documentation.
• Develop Auditing
  
  Skills:
  
  Participate in supplier and internal quality system audits as an Auditor‑in‑training, evaluating the effectiveness of our Quality System and good manufacturing practices.
• Lead Project Quality:
  Ensure quality conduct across projects—from design through data interpretation and report generation—for both your work and that of junior team members.
• Shape Our Future:
  Contribute to specific programs and projects that advance our quality capabilities, and prepare/revise policies and procedures that guide our organization.
• Own the Journey:
  Manage projects and tasks from product inception through launch and ongoing maintenance, ensuring products consistently meet quality standards at every stage.

• Bachelor’s degree in Engineering and 5 years relevant experience OR Master’s degree in Engineering and 3 years relevant experience.

• Applied knowledge of the FDA medical device quality system regulations and international quality system standards/regulations (e.g. 21
  
  CFR Part
  820, ISO
  13485, ISO
  14971, MDSAP, EUMDR/IVDR) as it relates to the design and continued support of BD products.
• Can ensure quality conduct of projects, including design, data summary and interpretation, and report generation for self and lower level project developers.
• Can independently determine and develop approach to solutions.
• Able to provide guidance and work direction to lower level project developers.
• Can design and perform development working independently within defined parameters with minimal supervision required.
• Experience with BD software systems utilized in the Quality Systems is desirable.
• Must have knowledge/specialization in one or more of the following areas:
  Acceptance sampling theory and application;
  Statistical process control methods and application;
  Measurement system/test method knowledge and analysis;
  Quality planning;
  Failure analysis investigation;
  Design of Experiments;
  Process mapping and value stream analysis;
  Hypothesis testing;
  Descriptive statistics;
  Process capability analysis;
  Basic quality tools:
  Pareto, box plots, histograms, scatter diagrams, etc.;
  Risk Management;
  Supplier quality management;
  Auditing;
  Design/development tools;
  Process validation;
  Software validation.

• Remote or field‑based positions will have different workplace arrangements indicated in the job posting.

Minimum 4 days of in‑office presence per week.

• Annual Bonus Potential
• Discretionary LTI Bonus
• Health and Well‑being Benefits
• Medical coverage
• Health Savings Accounts
• Flexible Spending Accounts
• Dental coverage
• Vision coverage
• Hospital Care Insurance
• Critical Illness Insurance
• Accidental Injury Insurance
• Life and AD&D insurance
• Short‑term disability coverage
• Long‑term disability insurance
• Long‑term care with life insurance
• Other Well‑being Resources:
  Anxiety management program;
  Wellness incentives;
  Sleep improvement program;
  Diabetes management program;
  Virtual physical therapy;
  Emotional/mental health support programs;
  Weight management programs;
  Gastrointestinal health program;
  Substance use management program;
  Musculoskeletal surgery, cancer…