Hybrid Quality Manager – EMI Quality Excellence

Posted 2 hours ago

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About the role

  • Quality Manager leading quality improvements and regulatory compliance for BD's medical technologies. Developing assurance programs and managing supplier quality across multiple sites with oversight responsibilities.

Responsibilities

  • Develop, maintain, and oversee EMI wide quality assurance programs, policies, and procedures.
  • Harmonize quality management system (QMS) processes across EMI plants to ensure consistency.
  • Support EMI sites during internal, external, and regulatory audits; conduct site visits and provide audit preparation.
  • Assist plants in defining and implementing quality system best practices.
  • Lead manufacturing quality initiatives and drive timely resolution of quality issues.
  • Manage product realization activities including line transfers and New Product Development (NPD) introductions.
  • Ensure manufacturing readiness for design & manufacturing transfers.
  • Support EMI plants with supplier oversight and manage related nonconformance investigations.

Requirements

  • Bachelor’s degree in Engineering, Quality, Life Sciences, or related field.
  • Minimum 5 years of experience in Quality Engineering, Supplier Quality or similar roles, in areas like Electromechanical Instrumentation and Quality Assurance.
  • Minimum 5 years of experience leading a team.
  • Demonstrated expertise in manufacturing processes, quality systems, and product realization workflows.
  • Strong experience with design controls, process validation, and NPD/NPI integration to manufacturing.
  • Lead Auditor certification (ISO 9001, ISO 13485, or equivalent).
  • Background working with CMOs and external suppliers.
  • Strong analytical and problem-solving skills with demonstrated root-cause expertise.
  • Excellent verbal and written communication skills across multiple levels of the organization.
  • Strong project management skills; able to manage multiple priorities in a fast-paced environment.
  • Ability to influence cross-functional partners and drive alignment across diverse teams.

Benefits

  • Health insurance
  • 401(k) matching
  • Flexible work hours
  • Paid time off
  • Professional development opportunities

Job title

Quality Manager – EMI Quality Excellence

Job type

Experience level

Mid levelSenior

Salary

$124,700 - $205,800 per year

Degree requirement

Bachelor's Degree

Location requirements

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