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Quality Engineer II (Complaints)

Apply Now Job ID R-26427 Date posted 12/07/2017

Job Description Summary

Acts as the main point of contact for customer complaints. Resolves moderate to complex customer complaints and works with the Associate Quality Manager (Supervisor) on critical and sensitive issues/customer complaints. Review, evaluate, investigate, analyze and resolve complaints and problems concerning Customers, through close coordination with Operations, Quality, Complaint Group, Marketing & Sales and, by obtaining understanding of customer product expectations and functional needs to represent the customer in-plant decisions. Manages the complaint process at the plant level from start to end.

Job Description

  • Develops solutions to routine problems of limited scope.
  • Follows company procedures for areas of assigned responsibility. Limited knowledge of applicable regulatory, Corporate and/or Unit requirements
  • Effective communicator; ensuring all complaints are acknowledged, investigated and completed in a timely manner.
  • Conducts evaluation of customer complaints; including documentation review, sample testing, and technical evaluation of product defects.
  • Manages the resolution of customer complaints, within given timeframes; identifying the problem, defining containment actions, investigating root cause, establishing corrective and preventive plans in order to eliminate or minimize the failures identified.
  • Works closely with Operations and Quality to identify potential root causes and develop and implement appropriate corrective and preventive actions.
  • Leads problem solving efforts to identify and resolve recurring and new quality issues to ensure production of safe and effective medical devices, which will result in product/process improvements, long-term solutions.
  • Tracks effectiveness of corrective action plans and compliance improvement initiatives.
  • Generates Situation Analysis Reports as needed, directed by the Associate Quality Manager (Supervisor), Quality Manager and other Directors in the Organization.
  • Analyzes data and identifies trends in order to develop innovative solutions; using statistical techniques to identify significant changes and proactively initiates plans/projects to mitigate the risk.
  • Generates weekly, monthly and quarterly reports and others as needed.
  • Provides feedback pertaining to the groups involved in the complaint process.
  • Maintains complaint files according to established polices/procedures.
  • Supports company goals and objectives, polices, and procedures to maintain compliance with ISO 13485, FDA QSR and CE mark compliance.
  • Maintain a professional working relationship with internal and external customer and support staff.

Skills

Limited / Basic application of technical principles, theories, concepts, techniques and quality sciences / tools such as:

  • acceptance sampling theory and application,
  • statistical process control methods and application,
  • measurement systems / test method knowledge and analysis,
  • quality planning,
  • failure analysis and investigation,
  • design of experiments,
  • process mapping and value stream analysis,
  • hypothesis testing,
  • descriptive statistics,
  • process capability analysis, and

Basic Quality Tools:

  • pareto,
  • box plots,
  • histograms,
  • scatter diagrams, etc...,
  • risk management,
  • supplier quality management,
  • auditing, design / development tools,
  • process validation, software validation, etc…

Qualifications

Education

  • BA/BS Degree (Major: Mechanical or Manufacturing Engineering)

Experience

  • Minimum of six months experience working  in a manufacturing environment

#LI-OPS

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.

Primary Work Location

USA CT - Canaan

Additional Locations

Work Shift

1st Shift 8am-430pm (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