Overall Job Summary: The incumbent will be responsible for providing technical support in the Customer Experience Engineering department by ensuring the quality of medical products are within all regulatory requirements and meet or exceed customer expectations. This will be accomplished by coordinating and executing complaint investigation activities including written investigations for root cause analysis (for part returns/no sample returns). Analysis and investigation includes the review of complaint trends, review of device history records, and testing of electromechanical systems and accessories.
Primary responsibilities will include:
* Completing complaint investigations for medical products down to root cause level for instruments/subassemblies, including trend review.
* Documentation of test methods and observed root causes.
* Drafting of Complaint Investigation Reports for part returns/no sample returns.
* Analysis of failure data across multiple product lines.
* Development and documentation of new test methods to improve the effectiveness and efficiency of test methods.
* Interfacing with multiple groups and levels within QA, R&D, Mfg, Service and IT.
* Completing complaint investigations for medical products down to root cause level for instruments/subassemblies, including trend review.
* Documentation of test methods and observed root causes.
* Drafting of Complaint Investigation Reports for part returns/no sample returns.
* Analysis of failure data across multiple product lines.
* Development and documentation of new test methods to improve the effectiveness and efficiency of test methods.
* Interfacing with multiple groups and levels within QA, R&D, Mfg, Service and IT.
Minimum Qualifications:
Bachelor's degree in EE, ME, IE or Biomedical Engineering required with 2 years Quality experience preferred. Prior experience with Regulatory Compliance and Complaint Investigations is a plus.
Bachelor's degree in EE, ME, IE or Biomedical Engineering required with 2 years Quality experience preferred. Prior experience with Regulatory Compliance and Complaint Investigations is a plus.
