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Senior Quality Engineer

Apply Now Job ID R-334327 Date posted 03/27/2019

Job Description Summary

This position monitors, works with, and develops suppliers to ensure that product and business quality requirements are met.

Job Description

Essential Job Functions:  

  • Support manufacturing, sustaining, and new product development supplier selection, assessment, and management.
  • Provide technical direction during supplier selection and development activities.
  • Create, revise, and sustain supplier quality business processes.
  • Monitor supplier performance through metrics, data collection, and analysis.
  • Work with cross-functional team to address supplier issues and develop new/existing suppliers.
  • Support teams with supplier corrective action process and investigations.
  • Schedule, coordinate, and/or conduct supplier audits. Participate in internal and supplier audits.
  • Follow up on supplier audit findings to ensure adequate responses.
  • Manage supplier compliance to company and industry requirements.
  • Train and mentor other groups on Supplier Quality requirements and best practices.
  • Create and revise Supplier Quality documentation and track through approval cycles and implementation.
  • Maintain Approved Supplier List and associated supplier documentation.
  • Participate and provide input to training on department/division procedures, and policies.
  • Participate in Supplier Quality project planning, scheduling, and tracking.
  • Understand and follow company procedures on regulatory requirements.

Basic Skills/Competencies Required:

  • Working knowledge of FDA Regulations, GMP/GLP, EU Medical Device Regulation, and ISO.
  • Ability to make and present engineering decisions
  • Strong interpersonal skills
  • Comparative statistics
  • Knowledge of Design of Experiments
  • Knowledge Statistical Process Control
  • Root Cause Analysis, Corrective Action, Preventive Action, Effectivness Verification
  • Manufacturing background preferred (knowledge of FMEA, Control Plans, Measurement System Analysis (MSA), First Articles, Validation – IQ/OQ/PQ)
  • Audit experience preferred
  • Ability to analyze manufacturing and quality systems and provide recommendations for improvement
  • Oral and written presentation skills
  • Must read, write and understand English.  Must be detailed in handling information/data.

Education Required:

  • A minimum of a Bachelors degree in a technical field.

Experience Required:

  • Five years experience in medical, automotive, aerospace field or closely related industry.

Physical Demands:

While performing the duties of this job, the employee is regularly required to stand, walk, sit and use hands to manipulate, handle or feel objects, tools, controls and office equipment.  The employee frequently is required to talk and hear. The employee is occasionally required to reach with hands and arms and stoop, kneel or crouch. 

Work Environment:

  • BD Peripheral Intervention is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce.
  • While performing the duties of this job, the employee may be in an open cubicle environment. Candidate must be able to work in a team-oriented, fast-paced environment.

Primary Work Location

USA AZ - Tempe BPV Building 4

Additional Locations

Work Shift

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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, or any other protected 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 asc.americas@bd.com