Post Market Quality Engineer in Marlborough, MA

100% onsite

Summary of Duties and Responsibilities:

This quality engineer is focused on Post Market Quality:

• Assess complaints and assign the applicable complaint failure mode and determine if escalation is required if the event is related to a Potential Adverse Event (PAE).
• Escalate events to the Clinical Specialists and/or PMS Manager when there is any Potential Adverse Event described.
• Testing of returned units from reported complaints.
• Ensure complaint investigation procedures are best in class and aligned with the requirements.
• Close complaints in a timely manner.
• Ensure KPIs are met in accordance with the established goals.
• Review and approve complaint investigations in the QMS, as required.
• Provide input to the organization regarding the information gathered from complaint investigations.
• Implement tools to ensure laboratory expenses are met in accordance with the approved budget and forecast.
• Innovate processes to improve efficiency and ensure compliance with the Post Market Surveillance’s requirements.
• Support Product Transfers.
• Participate, support and/or lead PMS projects
• Support and promote the implementation of EHS programs to ensure staff safety and environmental health.
• Communicate with OEMs and CMs, as needed and send the applicable complaint information to the corresponding vendor.
• Coordinate services with suppliers and availability of the required supplies in house. (as applicable).
• Coordinate and ensure that required payments to vendors are performed on time.
• Make decisions following a risk-based approach, implement tools as FMEA, Fault Tree Analysis (FTA) and risk evaluation.

Education

• University Bachelor's degree in engineering, or related career.

Specialized Knowledge (Desirable)

• Equipment qualification.
• Laboratory good practices.
• Test method and procedure development
• Statistics

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