Tekwissen
Manufacturing Quality Engineer
Tekwissen, San Jose, California, United States, 95199
Position : Quality EngineerLocation : San Jose, CA, 95134Duration : 2 MonthsJob Type : ContractWork Type:
OnsiteShift:
Monday to Friday 8.00 AM to 5.00 PM PSTPay Rate: $35 to $45 depending on experience and skill setOverviewTekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients world-wide. The job opportunity below is for one of our clients specializing in biotechnology product development services. Our client is dedicated to supplying laboratory equipment, chemicals, supplies, and services essential in healthcare, scientific research, safety, and education. As the global leader in serving the field of science, our client boasts an annual revenue of around $40 billion with a mission to empower customers to make the world healthier, cleaner, and safer. Our client's global team is committed to delivering an unparalleled blend of cutting-edge technologies, convenient procurement options, and pharmaceutical services under their industry-leading brands.Job Description:How will you make an impact?The Quality Specialist is responsible for leading corrective and preventive actions and customer complaints process.Quality Specialist is responsible for processing and closing all medical device/IVD, product safety complaints ensuring that all required documentation is maintained per the Complaint Handling Procedure.The Quality Specialist will perform the evaluation of customer complaints for Medical Device Report (MDR) and Vigilance reports (MDV).The Quality Specialist is also responsible for leading Corrective Action and Preventive Action (CAPA) program.This individual works directly with the cross functional CAPA owners to ensure that CAPA processes are closed optimally and on time.They also report Customer Complaints and CAPAtrending activities and metrics to management.What will you do?Initiate, update, and optimally close all product safety, medical device/IVD complaints.Lead all CAPA program activities including taking ownership of CAPA program and driving changes where appropriate.Establish and manage processes for implementing CAPAs and complaint handling in accordance with 21CFR§820 and ISO 13485.Advise manager of any potential reportable product safety incidents and work with Regulatory Affairs as appropriate.Work with Service organization to ensure accurate follow-up activities with the customer have taken place.Work with product investigators to ensure timely and effective investigation. Ensure adequate investigation has taken place for CAPAs and Root Cause Analysis is complete and appropriate for the issueReport CAPA and complaint trending data and metrics to management during quality reviews.Maintain professional demeanor with cross functional, technical and QA staff to acquire vital information to support documentation.Work cross functionally to initiate CAPAs from all identified sources, ensure timely completion of CAPA planning activities such as root cause analysis, containment, immediate corrections, corrective action plan and verification of efficiency plans.Perform other duties as required.How will you get here?Education:Minimum required education: Bachelor's degree.Degree in Science or Engineering is preferred.Experience:2-5 years as a QA professional (in a CE/IVD or FDA supervised company preferred).Experience in the medical device industry, pharma and/or highly supervised industry is preferred.A qualified auditor of ISO 13485 Quality Management Systems is preferred.Familiarity with SAP or analogous ERP software systems, Trackwise, MS Word, MS PowerPoint, MS Excel is preferred.Knowledge, Skills and Abilities:Ability to interact with individual/groups at all levels, good presentation/training skills.Ability to identify priorities and function independently.TekWissen® Group is an equal opportunity employer supporting workforce diversity.
OnsiteShift:
Monday to Friday 8.00 AM to 5.00 PM PSTPay Rate: $35 to $45 depending on experience and skill setOverviewTekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients world-wide. The job opportunity below is for one of our clients specializing in biotechnology product development services. Our client is dedicated to supplying laboratory equipment, chemicals, supplies, and services essential in healthcare, scientific research, safety, and education. As the global leader in serving the field of science, our client boasts an annual revenue of around $40 billion with a mission to empower customers to make the world healthier, cleaner, and safer. Our client's global team is committed to delivering an unparalleled blend of cutting-edge technologies, convenient procurement options, and pharmaceutical services under their industry-leading brands.Job Description:How will you make an impact?The Quality Specialist is responsible for leading corrective and preventive actions and customer complaints process.Quality Specialist is responsible for processing and closing all medical device/IVD, product safety complaints ensuring that all required documentation is maintained per the Complaint Handling Procedure.The Quality Specialist will perform the evaluation of customer complaints for Medical Device Report (MDR) and Vigilance reports (MDV).The Quality Specialist is also responsible for leading Corrective Action and Preventive Action (CAPA) program.This individual works directly with the cross functional CAPA owners to ensure that CAPA processes are closed optimally and on time.They also report Customer Complaints and CAPAtrending activities and metrics to management.What will you do?Initiate, update, and optimally close all product safety, medical device/IVD complaints.Lead all CAPA program activities including taking ownership of CAPA program and driving changes where appropriate.Establish and manage processes for implementing CAPAs and complaint handling in accordance with 21CFR§820 and ISO 13485.Advise manager of any potential reportable product safety incidents and work with Regulatory Affairs as appropriate.Work with Service organization to ensure accurate follow-up activities with the customer have taken place.Work with product investigators to ensure timely and effective investigation. Ensure adequate investigation has taken place for CAPAs and Root Cause Analysis is complete and appropriate for the issueReport CAPA and complaint trending data and metrics to management during quality reviews.Maintain professional demeanor with cross functional, technical and QA staff to acquire vital information to support documentation.Work cross functionally to initiate CAPAs from all identified sources, ensure timely completion of CAPA planning activities such as root cause analysis, containment, immediate corrections, corrective action plan and verification of efficiency plans.Perform other duties as required.How will you get here?Education:Minimum required education: Bachelor's degree.Degree in Science or Engineering is preferred.Experience:2-5 years as a QA professional (in a CE/IVD or FDA supervised company preferred).Experience in the medical device industry, pharma and/or highly supervised industry is preferred.A qualified auditor of ISO 13485 Quality Management Systems is preferred.Familiarity with SAP or analogous ERP software systems, Trackwise, MS Word, MS PowerPoint, MS Excel is preferred.Knowledge, Skills and Abilities:Ability to interact with individual/groups at all levels, good presentation/training skills.Ability to identify priorities and function independently.TekWissen® Group is an equal opportunity employer supporting workforce diversity.