- Understanding on Medical Device Quality and Compliance
- Knowledge on ISO 13485: 2019 and 21 CR 820
- Experience in Complaints Handling, Post Market Surveillance
- Knowledge on Medical Device Regulatory Standards, MDD and MDR
- Knowledge on NC, CAPA, Audit processes
- Medical Devices Risk Management. Can also identify less obvious risks in a given business opportunity.
- Experience with Application, Process, Design and System FMEA etc.
- Able to adapt to changing/emerging data requests from a variety of different system applications.
- Experience with statistical tools and techniques including DOE. Able to perform advanced descriptive and non-parametric statistical analyses.
- Experience in Medical Device Industry Quality and Compliance
- Experience in interpretation of regulations, standards and performing impact assessment on Quality system documents.
- Ownership to close CAPA, driving risk management activities.
- Experience in Post-Market-Surveillance, Complaint Management of Medical Device
- Provide technical support on organization's quality processes within QMS.
- Work with cross functional teams and internal teams to create deliverables.
- Meet delivery promise in terms of budget and timescales.
- Track Project progress and make necessary changes to project execution as needed to ensure achievement of project goals.
- Work within a multi-discipline team, consisting of the R&D Development Group, Marketing, Quality, Operations
- Liaison with customer designated point of contact and functional area point of contact.
- Multiple Project Planning and execution
- Take complete ownership of the quality aspects of the project including managing other quality associates working in the project.
- Knows whether to outsource based on capacity, criticality, and complexity of the activity.
Design Quality Engineer - Santee, United States - Siri InfoSolutions Inc
Description
Job Description
Job DescriptionPosition : Design Quality Engineer
Location: Santa Clara, CA
Job Type: Fulltime Job
Need Only USC / GC /GC EAD
Job Description :-
5+ years of work experience in the Medical Device industry in Design Quality role
Can translate stressors into an executable test that accurately predicts field reliability; able to use advanced statistics for prediction
Experience with ISO 14971 requirements, and can guide team to apply risk management system; knowledge of interconnections of FMEAs; can make decisions based on FMEA output
Interpret new/ upcoming quality/ regulatory requirements and provide guidance
Take a well thought out and planned approach involving multiple arguments or steps. Anticipates the interests, reactions, or objections of others and adapts a multi-part influence strategy