Hologic Post Market Surveillance Engineer 1 in Marlborough, Massachusetts
Escalate to the Clinical Specialists and PMS Manager in case there is any Potential Adverse Event.
Support other facilities and OEMs/CMs, as required.
Review and approve complaints investigations in the QMS, as required.
Provide guidance to product SMEs in technical matters related to Post Market Surveillance.
Execute investigations such as OOTs, NCEs, CAPAs, IACAs and/or similar. Ensure they are performed on time, in compliance with procedures and regulations.
Ensure equipment is properly calibrated and controlled within the QMS. Ensure Preventive Maintenance program is implemented as required.
Ensure testing and investigations are performed in accordance with the procedures and on a timely manner.
Support track and trend of complaints (as applicable).
Make decisions based on a risk thinking, implement tools as PFMEA, Fault Tree Analysis (FTA) and risk evaluation.
Control best in class metrics and quality reports related to Post Market Surveillance processes.
Maintain, improve, and simplify procedures, processes, and methods.
Support preparation of budget forecasts and ensure compliance with the approved budget.
Support and promote the implementation of EHS programs to ensure people safety and environment health.
Support improvement initiatives, NPIs, product transfers, implementation of new technologies.
Ensure supplies availability (as applicable) and coordinate with the corresponding suppliers (as needed).
Coordinate and ensure that required payments to vendors are performed on time.
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