Job Description Summary

This position is responsible for the Quality Assurance and Control processes within the Service organization. This position will be responsible to review the output of Servicing and Complaint Investigation activities to ensure that the resulting work complies with all regulatory requirements, as well as facility, divisional, and corporate objectives.

Job Description

Essential Job Functions:

• Ensure that Complaint Investigations and Servicing activities are thorough, complete, self-explanatory, and completed in a timely manner.
• Assist technicians in establishing investigation criteria and, as needed in troubleshooting returned products to identify root causes of failures
• Assist in quality investigations with Divisional Field Assurance and Engineering to identify causes of service and complaint trends.
• Provide ongoing training to Service staff on regulatory requirements associated with complaint investigations
• Review and approve completed service records for accuracy
• Participate in Product Transfer teams to assist in developing service repair processes for new or transferred products
• Participate in the development and review of engineering change orders that impact servicing activities
• Work with Engineering to design and implement tooling and fixturing required to perform servicing activities.
• Perform DHR, Service History record, and PFMEA reviews in support of complaint investigations
• Coordinate complaint investigation activities with divisional Field Assurance
• Review and monitor monthly service reports for trends
• Prepare monthly reports on Complaint Investigation findings and trends

Additional Job Functions:

• Support the goals of the Quality Organization, Continuous Improvement efforts and Cost Improvement Projects. 
• Other duties as required.

Basic Qualifications:

• Excellent technical report writing skills

• Strong Root Cause Analysis and Design Of Experiments/Investigation experience as related to Complaint Investigations
• A solid understanding of the FDA QSR Quality System Requirements, and the ability to apply the knowledge to comply with goals and objectives.
• Strong experience with MS Office Products (Word, Excel, Visio, Project, PowerPoint, Outlook, etc.)
• Excellent oral and written communication skills with the ability to communicate with audiences of varying technical skills
• A strong ability to prepare written technical plans and reports in support of engineering changes, product or process validations, and failure investigations.
• Strong focus on meeting customer needs.
• Ability to train/mentor electronic test technicians
• Ability to work with cross-functional teams.
• Demonstrated strong attention to detail and  “do it right the first time” attitude

Additional Desirable Qualifications Skills and Knowledge:

• Experience in an FDA regulated environment
• Experience in electro-mechanical troubleshooting techniques
• Experience in a customer focused service organization

• Familiarity with ISO14971 and associated Risk Management Processes
• Knowledge of and/or experience with product decontamination and Blood Borne Pathogen exposure controls
• Ability to work with and motivate people.
• Proven leadership skills in a fast pace environment.

Education and/or Experience:

• Bachelors Degree in an Engineering discipline (Electrical, Mechanical, Bio-Medical, etc)
• 1-3 years of experience in the manufacture of Electro-Mechanical devices
• 0-3 years experience in FDA regulated Medical Device Manufacturing

Work Environment:

• Majority of time is spent working in an office
• Ability to travel overnight (<5%)

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.

#LI-OPS

Primary Work Location

USA PA - Zelienople

Additional Locations

Work Shift

NA (United States of America)