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Service Quality Engineer

Zelienople, Pennsylvania 16063 | Contract

Post Date: 02/23/2018 Job ID: 75113 Category: Quality Engineers

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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.

Duties and Responsibilities:
  • 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.
  • 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.
  • Other duties as assigned.

  • 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.
  • Excellent technical report writing skills.
  • Strong Root Cause Analysis and Design Of Experiments/Investigation experience as related to Complaint Investigations.
  • 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 work with cross-functional teams.

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:
  • While performing the duties of this job, the employee may be in an office, open cubicle, and/or manufacturing environment.
  • Candidate must be able to work in a team-oriented, fast-paced environment.
  • Our client is an equal opportunity employer that values and actively seeks diversity in the workforce.

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