Design Quality Engineer

Position : 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

• 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.

Can translate stressors into an executable test that accurately predicts field reliability; able to use advanced statistics for prediction

• 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

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

• Provide technical support on organization's quality processes within QMS.
• Work with cross functional teams and internal teams to create deliverables.

Interpret new/ upcoming quality/ regulatory requirements and provide guidance

• 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.

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