Quality Engineer I - HireTalent
Marlborough, MA 01752
About the Job
Intake:
Pay rate: ***-***/hour
100% onsite
Summary of Duties and Responsibilities:
This quality engineer is focused on Post Market Quality:
o 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).
o Escalate events to the Clinical Specialists and/or PMS Manager when there is any Potential Adverse Event described.
o Testing of returned units from reported complaints.
o Ensure complaint investigation procedures are best in class and aligned with the requirements.
o Close complaints in a timely manner.
o Ensure KPIs are met in accordance with the established goals.
o Review and approve complaint investigations in the QMS, as required.
o Provide input to the organization regarding the information gathered from complaint investigations.
o Support preparation of budget forecasts and ensure compliance with the approved budget.
o Implement tools to ensure laboratory expenses are met in accordance with the approved budget and forecast.
o Innovate processes to improve efficiency and ensure compliance with the Post Market Surveillance s requirements.
o Support Product Transfers.
o Participate, support and/or lead PMS projects
o Support and promote the implementation of EHS programs to ensure staff safety and environmental health.
o Communicate with OEMs and CMs, as needed and send the applicable complaint information to the corresponding vendor.
o Coordinate services with suppliers and availability of the required supplies in house. (as applicable).
o Coordinate and ensure that required payments to vendors are performed on time.
o Make decisions following a risk-based approach, implement tools as FMEA, Fault Tree Analysis (FTA) and risk evaluation.
o Support other facilities and OEMs/CMs, as required.
o Ensure equipment is properly calibrated and controlled with the QMS. Ensure the Preventive Maintenance program is implemented as required.
o Execute investigations such as OOTs, NCEs, CAPAs, IACAs and/or similar. Ensure they are performed on time, in compliance with procedures and regulations.
" Qualifications
o Drive for Results
o Planning
o Organizational Agility
o Listening
o Decision making
o Problem Solving
o Communication
" Education
o University Bachelor's degree in engineering, or related career.
Specialized Knowledge (Desirable)
o FDA regulations (Including the MDR for Manufacturers Guidance), ISO 13485, ISO 14947, EU MDD/MDR and any related ISO and AAMI standards.
o Equipment qualification.
o Laboratory good practices.
o Test method and procedure development
o Statistics
Languages required for the position:
o Native English
" Computer tools and knowledge level required (Desirable) / Herramientas informa ticas y nivel de conocimiento requerido:
o Microsoft Office, Internet, Minitab, Oracle, Agile and H1.
Pay rate: ***-***/hour
100% onsite
Summary of Duties and Responsibilities:
This quality engineer is focused on Post Market Quality:
o 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).
o Escalate events to the Clinical Specialists and/or PMS Manager when there is any Potential Adverse Event described.
o Testing of returned units from reported complaints.
o Ensure complaint investigation procedures are best in class and aligned with the requirements.
o Close complaints in a timely manner.
o Ensure KPIs are met in accordance with the established goals.
o Review and approve complaint investigations in the QMS, as required.
o Provide input to the organization regarding the information gathered from complaint investigations.
o Support preparation of budget forecasts and ensure compliance with the approved budget.
o Implement tools to ensure laboratory expenses are met in accordance with the approved budget and forecast.
o Innovate processes to improve efficiency and ensure compliance with the Post Market Surveillance s requirements.
o Support Product Transfers.
o Participate, support and/or lead PMS projects
o Support and promote the implementation of EHS programs to ensure staff safety and environmental health.
o Communicate with OEMs and CMs, as needed and send the applicable complaint information to the corresponding vendor.
o Coordinate services with suppliers and availability of the required supplies in house. (as applicable).
o Coordinate and ensure that required payments to vendors are performed on time.
o Make decisions following a risk-based approach, implement tools as FMEA, Fault Tree Analysis (FTA) and risk evaluation.
o Support other facilities and OEMs/CMs, as required.
o Ensure equipment is properly calibrated and controlled with the QMS. Ensure the Preventive Maintenance program is implemented as required.
o Execute investigations such as OOTs, NCEs, CAPAs, IACAs and/or similar. Ensure they are performed on time, in compliance with procedures and regulations.
" Qualifications
o Drive for Results
o Planning
o Organizational Agility
o Listening
o Decision making
o Problem Solving
o Communication
" Education
o University Bachelor's degree in engineering, or related career.
Specialized Knowledge (Desirable)
o FDA regulations (Including the MDR for Manufacturers Guidance), ISO 13485, ISO 14947, EU MDD/MDR and any related ISO and AAMI standards.
o Equipment qualification.
o Laboratory good practices.
o Test method and procedure development
o Statistics
Languages required for the position:
o Native English
" Computer tools and knowledge level required (Desirable) / Herramientas informa ticas y nivel de conocimiento requerido:
o Microsoft Office, Internet, Minitab, Oracle, Agile and H1.
Source : HireTalent