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Palm Beach, Florida - USD Full Time Posted: Thursday, 7 December 2017
Principal Duties and Responsibilities - Process product complaints in a uniform and timely manner per established procedures.
- Direct urgent issues to the proper personnel for reportability decisions.
- Conduct complaint product testing and evaluation.
- Conduct and document accurate and thorough complaint investigations including review of DFMEA, P-FMEA and manufacturing documents where appropriate to ensure adequate identification, evaluation & investigation of an assignable root cause. Ensure quality issues are managed according to procedure and ensure adequate corrective/preventive actions are effective to eliminate/mitigate the issue.
- Initiate CAPA Determination for complaints as applicable.
- Support the rollout of any new CAPA solutions (tools, techniques, and/or process enhancements) in relation to the complaint investigation activities.
- Review and approve Product Evaluation Reports and complaints for final closure as applicable.
- Provide timely Health Hazard Evaluation (HHE) information from within the department and interdepartmentally, as needed to assist the HHE Coordinator.
- Identify and implement improvements and innovations that increase efficiency and enhance work quality.
- Participate in internal and external departmental audits and responses to cited issues.
- Follow safety guidelines applicable to the area.
- Perform related duties as required.
Expected Areas of Competence - Ability to work within a team environment and build relationships outside of the department as well as outside the company (suppliers, regulatory agencies, etc.).
- Facilitates team efforts on quality engineering projects.
- Ability to deliver, meet deadlines and have results orientation.
- Adapts and is flexible and resilient in response to constraints, failures, and adversity.
- Adjusts priorities to multiple demands and unanticipated events, and modifies decisions and actions in response to changing information and circumstances.
- Able to communicate both orally and in written form to multiple levels of the company.
- Microsoft Office Suite, expert knowledge of blueprint reading and geometric dimensioning and tolerancing, understanding of QSR/ISO regulations, design assurance, FMEA, and product testing methods, and are able to use optical comparators and CMMs.
- Knowledge of statistics, process control, and process capability
- Knowledge of the Quality System Regulation (21 CFR Part 820), the Medical Devices Directives (MDD) and other relations related to post market data.
- Full working knowledge of all supporting department needs and capabilities, including the ability to discern when inaccurate information is supplied and offer ideas for how to correct it.
- Thorough knowledge base of existing Zimmer Biomet products and a basic understanding of competitive products
Education/Experience Requirements - B. S. in engineering or an alternative Bachelor s degree program with certification as a quality engineer (e. g. CQE).
- Certification as a quality engineer (e. g. CQE) or the Reliability Engineer Certification (CRE) granted through the American Society of Quality (ASQ) preferred.
- 5-7 years experience in a Quality Engineering role; Medical device strongly preferred, or an equivalent combination of education and experience.
- Combination of education and experience may be considered (in evaluating experience relative to requirements)
Travel Requirements Up to 15%

Palm Beach, Florida, United States of America
Zimmer Biomet
Zimmer Biomet
12/7/2017 7:07:46 AM

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