Quality Assurance Specialist II - Integrated Resources, Inc
Marlborough, MA 01752
About the Job
Intake:
True Job Title: Post Market Quality Clinical Specialist 1
Pay Rate: ***-***/hour. (Submittal does not guarantee rate*** Manager will determine rate after interviews and it may be lower than what you submit the candidate at. Please make sure candidates know that due to the large range)
Remote - Central time preferred, but flexible.
3 months to start, goal to extend
Required:
" At least 3+ years Experience in reporting/filing MDRs to the FDA in the Medical Industry
" Must be able to make decisions about what is reportable and what is not
" Must be able to hit the ground running with limited training. This team does not have bandwidth to do training
" Cannot be a fresh grad. Experience is required
Position Reports to Post Market Quality Manager or Sr Manager, or Post Market Quality Clinical Specialist 2 or 3.
Organizational Relationships / Quality, Supply Chain, Production, Manufacturing Engineering, Distribution, NPI, OEMs/CMs, RA, DA, R&D, Technical Services, Marketing, Clinical Affairs
Summary of Duties and Responsibilities
o Assess Potential Adverse Events as per the corresponding regulations and procedures.
o Submit Adverse Events/Serious Injuries and follow up reports in accordance with the applicable procedures and on a timely manner.
o Follow-up with the end users and any internal department (as Tech Support) for any additional information to Adverse Event/Serious injuries reporting.
o Ensure Good Faith Efforts made to the customer are completed and documented in a timely manner within *** s QMS.
o Submit Adverse Events/Serious Injuries reports when a MedWatch or any other notification is received (from Notified Bodies, Regulatory Agencies and other sources as PSURs).
o Ensure customer communications (as applicable) are created and issued in a timely manner.
o Ensure metrics and indicators related to adverse events/serious injuries reporting are under control.
o Support complaint handling for products manufactured by *** and OEMs/CMs, as required.
o Provide support to any response to Regulatory Agencies when follow up questions are submitted to ***.
o Make decisions based on a risk thinking and Risk Management Files.
o Support investigations such as NCEs, CAPAs, IACAs and/or similar. Ensure they are performed on time, in compliance with procedures and regulations.
o Participate in Internal and External Audits/Inspections and Assessments as needed.
o Innovate processes to improve efficiency and ensure compliance with the Post Market Surveillance s requirements.
o Support the implementation of EHS programs to ensure people safety and environment health.
Qualifications
o Drive for Results
o Planning
o Organizational Agility
o Listening
o Decision making
o Communication
Education
o University Bachelor's degree in physicians, nurses, and biomedical engineers or related career.
Experience
o Previous experience with Medical Device Reporting.
o Clinical Background.
Specialized Knowledge (Desirable)
o FDA regulations (Including the MDR for Manufacturers Guidance), ISO 13485, ISO 14971, EU MDR and any related ISO and AAMI standards.
o Statistics.
Languages preferred for the position
o Spanish(Advanced level)
Computer tools and knowledge level required
o Microsoft Office
True Job Title: Post Market Quality Clinical Specialist 1
Pay Rate: ***-***/hour. (Submittal does not guarantee rate*** Manager will determine rate after interviews and it may be lower than what you submit the candidate at. Please make sure candidates know that due to the large range)
Remote - Central time preferred, but flexible.
3 months to start, goal to extend
Required:
" At least 3+ years Experience in reporting/filing MDRs to the FDA in the Medical Industry
" Must be able to make decisions about what is reportable and what is not
" Must be able to hit the ground running with limited training. This team does not have bandwidth to do training
" Cannot be a fresh grad. Experience is required
Position Reports to Post Market Quality Manager or Sr Manager, or Post Market Quality Clinical Specialist 2 or 3.
Organizational Relationships / Quality, Supply Chain, Production, Manufacturing Engineering, Distribution, NPI, OEMs/CMs, RA, DA, R&D, Technical Services, Marketing, Clinical Affairs
Summary of Duties and Responsibilities
o Assess Potential Adverse Events as per the corresponding regulations and procedures.
o Submit Adverse Events/Serious Injuries and follow up reports in accordance with the applicable procedures and on a timely manner.
o Follow-up with the end users and any internal department (as Tech Support) for any additional information to Adverse Event/Serious injuries reporting.
o Ensure Good Faith Efforts made to the customer are completed and documented in a timely manner within *** s QMS.
o Submit Adverse Events/Serious Injuries reports when a MedWatch or any other notification is received (from Notified Bodies, Regulatory Agencies and other sources as PSURs).
o Ensure customer communications (as applicable) are created and issued in a timely manner.
o Ensure metrics and indicators related to adverse events/serious injuries reporting are under control.
o Support complaint handling for products manufactured by *** and OEMs/CMs, as required.
o Provide support to any response to Regulatory Agencies when follow up questions are submitted to ***.
o Make decisions based on a risk thinking and Risk Management Files.
o Support investigations such as NCEs, CAPAs, IACAs and/or similar. Ensure they are performed on time, in compliance with procedures and regulations.
o Participate in Internal and External Audits/Inspections and Assessments as needed.
o Innovate processes to improve efficiency and ensure compliance with the Post Market Surveillance s requirements.
o Support the implementation of EHS programs to ensure people safety and environment health.
Qualifications
o Drive for Results
o Planning
o Organizational Agility
o Listening
o Decision making
o Communication
Education
o University Bachelor's degree in physicians, nurses, and biomedical engineers or related career.
Experience
o Previous experience with Medical Device Reporting.
o Clinical Background.
Specialized Knowledge (Desirable)
o FDA regulations (Including the MDR for Manufacturers Guidance), ISO 13485, ISO 14971, EU MDR and any related ISO and AAMI standards.
o Statistics.
Languages preferred for the position
o Spanish(Advanced level)
Computer tools and knowledge level required
o Microsoft Office
Source : Integrated Resources, Inc
