SouthSanFranciscoRecruiter Since 2001
the smart solution for South San Francisco jobs

Sr. Quality Engineer - Complaint Handling

Company: Fluidigm Corporation
Location: South San Francisco
Posted on: May 3, 2021

Job Description:

Job DescriptionSr. Quality Engineer - Complaint Handling South San Francisco, CANow is an exciting time for Fluidigm, and we want you to join us! We have placed our first In Vitro Diagnostic product on market and have pipeline of new products planned to make an impactful difference in clinical diagnostics. The quality and regulatory organization at Fluidigm is a cohesive group of professionals who enjoy what they do and have fun doing it! We invite all candidates who meet the qualifications below to apply for the opportunity to contribute to a dynamic and growing team.Essential Duties andResponsibilities:Oversee the complaint handling process for IVD and RUO products from intake through closure. This includes coordination of investigation activities with cross-functional stakeholders and project management responsibilities to ensure complaints are investigated and closed in a timely manner.Participate as the voice of QA in Design Control projects related to instrument, consumable and/or reagent development for RUO and IVD products.Assemble Design History Files and Device Master Records in electronic QMS for assigned Design Control projects.Lead risk management activities related to assigned Design Control projects, including risk management planning, design FMEA and risk management reporting.Responsible for reviewing Change Orders and performing QA approval of documents for assigned Design Control projects, including technical review of documents, plans, reports and Batch Records for accuracy.Perform QA processes in assistance of Operations functions. Participate in CAPA and nonconformance processes, as needed. Assist with the continual improvement of the Fluidigm Quality Management System at the SSF site and across other sites. May be called upon to review batch records and disposition of product for reagent manufacturing in-process and finished goods. Required Education/Experience: Technical Degree (BS or higher) in a biological or chemical science and 5 - 8 years of experience working within/developing Quality Systems in compliance with ISO 13485, FDA QSR (21 CFR 820) and European regulations/standards (IVDD/IVDR). Prior experience managing/overseeing risk management (ISO 14971) and design control required. Strong ability to work in a remote setting.The ability to work across the organization with all levels of employees to ensure that the value of the Quality Programs are understood and embraced. Experience with in vitro diagnostic medical device product required. The ability to work across the organization with all levels of employees to ensure that the value of the Quality Programs are understood and embraced. Ability to work in a dynamic & fast paced environment. Must be a strong communicator with peers, team members, and management. Fluidigm is an equal opportunity/affirmative action employer. We will consider all qualified applicants for employment without regard to race, color, religion, sex, age, or national origin. Internal Job Info Sr. Quality Engineer - Complaint Handling South San Francisco, CANow is an exciting time for Fluidigm, and we want you to join us! We have placed our first In Vitro Diagnostic product on market and have pipeline of new products planned to make an impactful difference in clinical diagnostics. The quality and regulatory organization at Fluidigm is a cohesive group of professionals who enjoy what they do and have fun doing it! We invite all candidates who meet the qualifications below to apply for the opportunity to contribute to a dynamic and growing team.Essential Duties andResponsibilities:- Oversee the complaint handling process for IVD and RUO products from intake through closure. This includes coordination of investigation activities with cross-functional stakeholders and project management responsibilities to ensure complaints are investigated and closed in a timely manner.- Participate as the voice of QA in Design Control projects related to instrument, consumable and/or reagent development for RUO and IVD products.- Assemble Design History Files and Device Master Records in electronic QMS for assigned Design Control projects.- Lead risk management activities related to assigned Design Control projects, including risk management planning, design FMEA and risk management reporting.- Responsible for reviewing Change Orders and performing QA approval of documents for assigned Design Control projects, including technical review of documents, plans, reports and Batch Records for accuracy.- Perform QA processes in assistance of Operations functions. - Participate in CAPA and nonconformance processes, as needed. - Assist with the continual improvement of the Fluidigm Quality Management System at the SSF site and across other sites. - May be called upon to review batch records and disposition of product for reagent manufacturing in-process and finished goods. Required Education/Experience: - Technical Degree (BS or higher) in a biological or chemical science and 5 - 8 years of experience working within/developing Quality Systems in compliance with ISO 13485, FDA QSR (21 CFR 820) and European regulations/standards (IVDD/IVDR). - Prior experience managing/overseeing risk management (ISO 14971) and design control required. - Strong ability to work in a remote setting.- The ability to work across the organization with all levels of employees to ensure that the value of the Quality Programs are understood and embraced. - Experience with in vitro diagnostic medical device product required. - The ability to work across the organization with all levels of employees to ensure that the value of the Quality Programs are understood and embraced. - Ability to work in a dynamic & fast paced environment. - Must be a strong communicator with peers, team members, and management. Fluidigm is an equal opportunity/affirmative action employer. We will consider all qualified applicants for employment without regard to race, color, religion, sex, age, or national origin. JobSummaryReq No.: 2021-3360Category: Quality Assurance / RegulatoryType: RegularSDL2017

Keywords: Fluidigm Corporation, South San Francisco , Sr. Quality Engineer - Complaint Handling, Other , South San Francisco, California

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Log In or Create An Account

Get the latest California jobs by following @recnetCA on Twitter!

South San Francisco RSS job feeds