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Job Posting Title
R&D7892-Product Surveillance Senior Engineer II

Principal Duties & Responsibilities
- Investigates customer complaints, drives timely root cause analysis, assesses the scope of complaints, and leads HHE creation as necessary to assess patient/user risk.
- Interfaces with Development, Manufacturing, Quality Assurance, and other functional areas to ensure thorough issue root cause, identify and formulate corrective actions, and initiate corrective action plans where applicable.
- Leads product quality trend data reviews within the department and across Product Surveillance.
- Authors explant examination reports and other written documentation for internal and external customers as required.
- Provides product and process technical training to salaried and hourly staff members.
- Compiles materials for management reviews, QSR training, and regular complaint reviews.
- Prepares and presents cases to the Remedial Action Screening Meeting as necessary.
- 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.

Job Summary
Independently responsible for the investigation and resolution of product complaints of all scopes for the U.S. Reconstructive and Trauma divisions (implants and instruments). Fosters positive relationships with supporting functional areas to resolve product and process issues and drive continuous improvement. Leads detailed investigations, product trend reviews, and department continuous improvement initiatives. Prepares and presents product safety and quality issues to the Remedial Action Screening Meeting. Provides product and process technical leadership/coaching to salaried and hourly staff. Must be committed to corporate goals of customer satisfaction and continuous improvement.

Expected Areas of Competence (KSA's)
- Position requires extensive knowledge of Zimmer products, Zimmer business practices, and Zimmer business management systems.
- Individual should be proficient with use of complaint and quality related IT systems and tools.
- Effective technical report writing skills.
- Excellent oral and written skills required.
- Effective leadership, interpersonal, negotiating, and conflict resolution skills
- Effective leadership skills.
- Able to work independently in most cases.

Education/Experience Requirements
- BS in an engineering discipline or bachelorýý s degree in another field with ASQ CQE certification plus a minimum of 6-8 years experience in a process engineering, development engineering, quality engineering or regulatory compliance role within the medical device, an FDA-regulated, or precision product environment, or an equivalent combination of education and experience.