Lead Product Quality Engineer

Provide product quality engineering support for on-market medical devices and serve as the product expert for assigned product lines and processes. This role will be responsible for performing evaluations, investigations, risk assessments and root cause analysis in relation to post-market feedback and complaints from the field. This includes leading cross functional teams in implementation of improvements or corrections based on the results of complaint investigations.

Additionally, the role will include mentoring Product Quality Engineers to build technical capability and drive consistent, high-quality investigations.

The incumbent may be asked to perform other function-related activities in addition to the below-mentioned responsibilities as reasonably required by business needs.

• Serve as the product expert for assigned product lines, developing in-depth knowledge of product design, functionality, clinical use, known failure modes, and product risk management documentation as applicable.
• Serve as process owner and subject matter expert for Product Quality Engineering processes and associated procedures, ensuring they remain compliant, effective, and consistently applied across teams. Provide training and mentorship to Product Quality Engineers on processes and procedures as needed.
• Coach/mentor Product Quality Engineers, providing technical guidance on complaint investigations, root cause analysis, Risk Management, risk assessment (including Health Risk Assessments and Health Hazard Evaluations), test method validation and documentation. Additionally, review documentation for technical quality and compliance.
• Lead and provide coaching on the prioritization, evaluation and documentation of complaints and investigations based on product risk to ensure timely completion of investigations.
• Drive consistency and best practices across the Product Quality Engineering team, including implementation of any improvement opportunities (new tools, technologies, and methods).
• Lead investigations and associated root cause analysis, including coordinating collaboration and communication with stakeholders.
• Partner with cross functional team and communicate root cause, determine if CAPA is required, recommended changes and scope effort to implement changes as needed.
• Responsible for executing the Health Risk Assessment and Health Hazard Evaluation, and coordinating with internal teams when needed, for evaluation of on market product, leading an efficient and effective analysis of situation, including problem definition and impact.
• Perform data analysis and trending of data related to complaints and identified failure modes, identifying mitigations for any threshold risks and owning preparation and presentation of data and findings to internal stakeholders where applicable.
• Lead cross functional team to implement design or process change including drawing update, fixture and tooling update, performing testing and change control documentation, as applicable.
• Develop or improve testing methods used during complaint investigation and root cause activities.
• Train and mentor the complaint intake team to build technical product knowledge and improve complaint evaluation quality, providing expertise on complex investigations as needed.
• Assess changes of products for impact to design and risk management, determine supporting information required for implementation of changes.
• Provide Post-Market feedback, identified through complaint trending and other forums, to Operations, Engineering and R&D to improve design and manufacture of devices in the field and in development.
• Lead investigations in the field at customer sites partnering with field-based teams, including sales and service.
  
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