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Senior Quality Engineer

Apply Now Job ID R-25492 Date posted 01/12/2018

Job Description Summary

The Senior Quality Engineer has responsibility for applying/interpreting the applicable Quality Systems, developing/implementing the Standard Operating Procedures and policy’s for an organization, such as Quality control, or a manufacturing plant.

Job Description


The Senior Quality Engineer is responsible for all aspects (product and process) related to the quality of the Instrument Plant for the designated product line(s). This includes manufacturability of products at the Instrument Plant, supplier manufacturing, customer requirements and complaints.  The Senior Quality Engineer will be responsible for developing and maintaining the Design History File, product and supplier quality.  Develops, modifies, applies and maintains quality standards and protocols. Additional responsibilities include:

  • Maintain FDA (Food & Drug Administration) and ISO (International Organization for Standardization) regulatory requirements. Key elements of focus are (but not limited to) product design for manufacturability, customer complaints, assembly and test, inspection and validation throughout the development process.
  • Generate process/product quality information in the form of Critical to Quality indices and share with project team/operations recommendations and solutions to emerging issues.
  • Improve key quality metrics (Fist Pass Acceptance, Quality Notifications and Complaint data).
  • Develop department programs / processes on continuous improvement and standardization across the BD Diagnostic Systems.
  • Supports the coordinated integration of new products into Manufacturing / Operations.
  • Ensures BD Diagnostic Systems divisional, departmental policies, procedures, practices and facilities are in compliance with all applicable regulatory policies.
  • Develop Design / Device History Files and maintain in a manner consistent with FDA (Food and Drug Administration) requirements
  • Understanding of Quality Systems and procedures


  • Bachelor’s degree with 5 years of experience in a regulated environment or MS with 3 years of experience. Typical degree in Electrical or Mechanical or Biomedical Engineering.
  • Experienced in Microsoft Office suite skills.  Basic mini tab and/or related analytical software programs

  • Sound workable knowledge and understanding of the Food and Drug Administration (FDA) 21 CFR 820 and International Organization for Standardization (ISO) ISO 9000:2000 and ISO 13485:2003.


  • Certification such as ASQ-CQA/CQE, AAMI, Six Sigma or a Company certification such as Green Belt, Black Belt, IGQA auditor.

Primary Work Location

USA MD - Baltimore

Additional Locations

Work Shift

NA (United States of America)
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Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status.

All applicants should complete the on-line application process. BD is committed to working with and providing reasonable accommodations to individuals with disabilities. If you require assistance or an accommodation because of a disability to participate in the application process, please call 855-BD-HELPS (855-234-3577) or email