PMS Specialist 3 CR (BB-0AE71)
Encontrado en: Neuvoo CR
· Education / Educación:
oUniversity Bachelor's degree in Engineering or similar.
· Experience / Experiencia:
o5 years on position of similar responsibility, decision making andproblems resolution.
· Specialized Knowledge (Desirable) / Conocimientoespecializado (preferible) :
oFDA regulations (Including the MDR for Manufacturers Guidance), ISO13485, ISO 14947, EU MDD/MDR and any related ISO and AAMI standards.
· Summary of Duties and Responsibilities / Resumen defunciones y responsabilidades:
oSupport Operational Excellence program and related initiatives.
oSupport local and extended CSPOs, VIP projects, improvement initiatives,NPIs, product transfers, implementation of new technologies.
oDevelop, control, and analyze best in class metrics and quality reportsrelated to the implemented in the Post Market Surveillance Laboratory.
oInnovate processes to improve efficiency and ensure compliance with thePost Market Surveillance’s requirements.
oImplementation of cost reduction projects that support businessstrategies.
oMaintain, improve, and simplify procedures, processes, and methods.
oSupport preparation/execution of budget forecasts and ensure compliancewith the approved budget.
oSupport and promote the implementation of EHS programs to ensure peoplesafety and environment health.
oExecute investigations such as OOTs, NCEs, CAPAs, IACAs and/or similar.Ensure they are performed on time and in compliance with procedures andregulations.
oParticipate in Internal and External Audits/Inspection and Assessments.
oEngage owners on determination of effective CAPAs.
oPerform queries to provide complaint data and ad hoc trend analysis onreported product problems/complaints.
oResolve a variety of issues, including fulfillment, assay, and instrumentcomplaints.
oResponsible for escalated complaints. Can place material on qualityhold, after approval by QA Management.
oFacilitator on moderate to complex investigations and conduct timely andinsightful response to investigations.
oPerform department metrics and works with others to ensure departmentgoal are met.
oPrepare agendas, facilitates cross functional meetings, and createsmeeting minutes with supervision.
oWork with Technical Service and/or Field Service to ensure appropriaterequired information is documented in complaint.
oWork on problems of moderate to major in scope where analysis ofsituation or data requires a review of a variety of factors.
oWork on transfer of information for new products to the rest of the PMSteam.
oEnsure customer communications are created and issued; review customerresponses for technical accuracy related to Hologic products
oReview other customer communication (response letters, acknowledgementletters) as appropriate.
oFollow-up with the end users / customers for any additional informationto support investigations
oSupport risk assessments and Health Hazard Evaluation (HHE) processes.
oLead and facilitates cross functional meetings.
oMake decisions based on a risk thinking, PFMEA, Fault Tree Analysis (FTA)and risk evaluation.
oSupport other facilities and OEMs/CMs, as required.
oLead and/or provide guidance to CSPOs, inspectors, technicians, supervisors,and engineers in technical matters related to Post Market Surveillance.
calendar_todayhace 3 días