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Quality Engineer II - Medical Device Manufacturing

Apply Now Job ID R-324798 Date posted 12/05/2018

Job Description Summary

The Quality Engineer provides critical quality engineering support to the manufacturing and quality operations.  Working in a product family and/or common transformation process alignment, the incumbent will understand, improve, and control operational processes in order to realize predictable product flow while satisfying established BD standards of quality.  This position provides collaborative support to quality system leadership to assure compliance with all BD quality policies, procedures and practices through consistent application of sound quality engineering/assurance principles.  Successful performance requires close work with quality management, operations, suppliers and/or BD associates.

Job Description

Responsibilities

  • Focus on Customer complaints, provide investigation and cordination of implementation of corrective actions.
  • Establishes a strong working relationship with all levels of operations in order to appropriately monitor and analyze in-process inspection, process control activity, waste and reject rates, PM compliance, environmental control and customer complaint levels in order to take a lead role in identifying and documenting continuous improvement projects.
  • Provides accurate and timely internal/external communication of process/production/project issues such as material inputs, process control, product quality, process/product improvements and assigned projects
  • Leads and assures appropriate CAPA activities to accomplish internal/external objectives.
  • Formulates, reviews and implements policies and procedures relating to product quality and process control as appropriate.
  • Mentors and trains project/team associates in sound quality engineering principles as appropriate.
  • Stays informed of quality engineering and quality system principles focused on compliance to worldwide regulations and corporate policies with respect to medical devices.

Requirements

  • Bachelors degree required in science related field.
  • Three (3) years experience in a high speed manufacturing environment.
  • Broad background in quality.

Preferred Skills

  • ASQ Certified Quality Engineer (CQE)
  • ASQ Certified Quality Auditor (CQA)
  • Experience with Software and Process Validation, SPC, FMEA and Risk Management.
  • Experience working in medical device (ISO/QSR) or other regulated manufacturing industry.
  • Experience working with cross functional teams.

Knowledge/Skills/Abilities:

  • Working knowledge of automated high speed manufacturing and inspection processes and computer controls.
  • Working knowledge of customer complaints.
  • Working knowledge of industrial quality control and statistical methods for data/measurement analyses.
  • Excellent verbal and written communication skills.
  • Proficiency in MS Word, Excel and Project.
  • Experience on Trackwise

Supervision

  • Indirect supervision of technicians and other support personnel may be necessary for assigned project completion

Primary Work Location

USA NE - Holdrege

Additional Locations

Work Shift

1st Shift 8am-5pm (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 asc.americas@bd.com