23 days old

Product Surveillance Senior Engineer I (612002)

Zimmer US
Dover, OH
  • Job Code
    135147

Job Summary





Responsible for the investigation and resolution of product complaints of all scopes for the U.S. Reconstructive division. Required to communicate in an effective manner with internal employees, the sales force, and medical professionals. Cooperates with a staff of salaried and technical employees. Must be committed to corporate goals of customer satisfaction and continuous improvement.



Principal Duties and Responsibilities





Performs quality engineering analysis and response for complaint files.
Authors explant examination reports and other written documentation for internal and external customers as required.
Evaluates scope of complaints and conducts risk-assessment.
Investigates claims and performs root cause analysis; develops corrective action plans for complaint issues.
Leads and oversees alliance partners in compliance to complaint and remedial action activities as stipulated in their operating specifications. Documents alliance complaint product and activity.
Works with development, suppliers, manufacturing, engineering, and other functional areas to formulate corrective actions and ensure implementation is complete and remedial actions are taken.
Develops useful metrics to gauge and encourage increased customer satisfaction.
Key point person for the sales force and health care professionals to verify and clarify complaint information.
Responsible for training others and the compilation of materials for management reviews, QSR training, and annual complaint reviews.
Serves as Core Team member for the Product Surveillance Department at various design review, testing protocol, and PRPR functions.
Supports Product Surveillance Department in all aspects of investigations and corrective actions arising from complaints and recalls.
Serves as point person for the Audit Department or other functional areas in compliance and process audits as required.
Works independently with little Supervision required; addresses issues without prompting by the Supervisor much of the time.



Expected Areas of Competence





Position requires extensive knowledge of Zimmer products, Zimmer business practices, and Zimmer business management systems.
Individual should be proficient with use of JDE, DCS, Impromptu, database creation and management.
Should have experience in writing reports and developing metrics.
Excellent oral and written skills required.



Education/Experience Requirements





BA in an engineering discipline or bachelors degree in another field with ASQ CQE certification plus a minimum of 5-7 years experience in a process engineering, development engineering, quality engineering or regulatory compliance role within the medical device or an FDA-regulated environment.



Travel Requirements





Up to 10%



Additional Information





EOE M/W/Vet/Disability







Posted: 2018-09-27 Expires: 2018-10-26
Sponsored by:
Farm Credit Services of America Logo
Sponsored by:
Bank of America Logo

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Product Surveillance Senior Engineer I (612002)

Zimmer US
Dover, OH

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