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TalentBurst, an Inc 5000 company · 2 days ago
Sr Quality Engineer
Irvine, CA
Contract
Hybrid
Senior Level
4+ years exp
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Responsibilities
Manage end-to-end CAPA process with the support of SMEs from a cross-functional team. Work with the CAPA owners and lead investigations of complex manufacturing product quality and compliance issues (e.g., CAPA, audit observations) for all production processes based on engineering principles. Perform robust root cause analysis investigation, develop, and implement corrective actions, and establish effectiveness monitoring plans.
Manage all phases of the CAPA process for specific events, including documentation, root cause analysis investigation, record management, and assembly of robust CAPA files within the CAPA Management System.
Apply knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements.
Quality Systems Engineering support, including Post-Market Quality Engineering support.
Guide others in resolving basic issues in specialized areas based on existing solutions and procedures.
Train, coach, and guide employees on CAPA procedures.
Other incidental duties assigned by Leadership.
Qualification
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Required
Bachelor’s Degree in Engineering or related field plus 4 years relative regulated industry experience required; Electrical Engineering degree preferred.
Working knowledge of the Domestic and International regulatory Medical Device regulations (FDA 21 CFR 820, ISO 13485; and other applicable regulatory requirements).
Need somebody with CAPA and Root Cause Analysis investigation experience.
Hands on engineering experience with electronics preferred.
ASQ Certified Quality Engineer (CQE), Quality System Lead Auditor, Certified Six Sigma Black Belt (CSSBB), or related quality/regulatory certifications preferred.
Engineering degree, CAPA experience, investigation experience, technical skills, team player, independent, quality experience.
Preferred
Master’s Degree will offset one (1) year of required experience.
ASQ Certified Quality Engineer (CQE), Quality System Lead Auditor, Certified Six Sigma Black Belt (CSSBB), or related quality/regulatory certifications preferred.
Experience with automation, software testing, and software validation is strongly preferred.
Project Management
Professional level proficiency with MS Office Suite (Outlook, Word, Excel, PowerPoint, MS Project)
Extensive knowledge and understanding and knowledge of principles, theories, and concepts relevant to Quality Engineering (e.g., CQE body of knowledge)
Knowledge of Six Sigma concepts with the ability to apply to work product.
Working knowledge and understanding of statistical techniques.
Ability to read and interpret drawings.
Strong leadership skills and ability to influence change.
Ability to prioritize, plan & evaluate deliverables to establish strategic goals.
Proficient knowledge of Quality Engineering concepts relative to the level of role (Senior Engineer)
Must be able to work in a collaborative team environment, including inter-departmental teams and key contacts for internal and outside customers.
May work on resolution of complex technical issues or projects where precedent may not exist
Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of the environment and prevention of pollution under their span of influence/control.
Company
TalentBurst, an Inc 5000 company
Founded in 2002, TalentBurst is a certified MBE firm that provides award winning solutions globally including: IT/Eng, Prof, & F&A Staffing Life Sciences & Clinical Staffing SLED (State, Local, Education) Staffing High Hazard & Global Payroll 1099/IC Validation & Compliance Recognitions & awards include: 2023 Top Workplaces Best Place to Work 2023 Top Workplaces Culture Excellence 2023 World Staffing Summit Top 100 Staffing Firms to Work For 2023, 2022 SIA Diverse Owned Staffing Firms 2021 BBJ #1 Largest MBE Enterprise in MA 2020-2021 BBJ Fast50 2020 SIA Large Life Sciences Staffing Firms 10 time BBJ Pacesetter & INC 500/5000 5 time SIA-fastest growing GNEMSDC Supplier of Year Category 4 2019-2020 AgileOne Diverse Supplier of the Year 2021 AgileOne Gold Supplier 2017 Allegis Global Solutions Strategic Partner 2018-2023 Allegis Global Solutions Diversity Partner of the Year 2020 Coupa Advantage and Link Silver Partner Magnit Global Supplier Excellence 2023 PRO Unlimited Silver, Gold, & Platinum Supplier 2012-2020 PRO Unlimited VOP Supplier of the Year 2020 Randstad Premier Supplier 2021-2023 TAPFIN Premier Partner 2017-2018 Workforce Logiq Proven Performer 2016-2020 First Data #1 supplier for 12 Quarters Thermo Fisher Supplier of the Quarter Toyota Best in Compliance & Retention Excellence Dominion Energy Supplier of the Year 2020 Western Union Supplier of the Year 2017 Top Supplier for PerkinElmer, VISA, Mass Mutual, and more! We currently have workforce in 46 states & 12+ countries for customers such as Amazon, Apple, VISA, Exelon, Securian, Salesforce, Dropbox, Twitter, Otsuka, Adobe, Western Union, First Data, FIS, SANOFI, Merck, Abbott, Roche, Dell, and Corning among many others.
1,001-5,000 employees
H1B Sponsorship
TalentBurst, an Inc 5000 company has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Trends of Total Sponsorships
2023 (5)
2022 (1)
2021 (1)
2020 (2)
Funding
Current Stage
Late StageLeadership Team
Jamie Jacobs (she/her)
Sr Vice President of Strategic Partnerships and DE&I/ESG Council
Recent News
The Swellesley Report
2023-12-24
2023-12-24
Company data provided by crunchbase
