We have other current jobs related to this field that you can find below
-
Senior Supplier Quality Engineer, NPD
2 months ago
Irvine, United States Edwards Lifesciences Full timeEdwards Lifesciences has an opportunity for a Senior Engineer, Supplier Quality on the Transcatheter Mitral and Tricuspid Therapies (TMTT) team. This cross-functional position will have a primary focus to lead in the development, improvement, maintenance, and management of suppliers. The Senior Engineer will apply knowledge of quality engineering principals...
-
Senior Supplier Quality Engineer, NPD
6 days ago
Irvine, United States Edwards Lifesciences Full timeEdwards Lifesciences has an opportunity for a Senior Engineer, Supplier Quality on the Transcatheter Mitral and Tricuspid Therapies (TMTT) team. This cross-functional position will have a primary focus to lead in the development, improvement, maintenance, and management of suppliers. The Senior Engineer will apply knowledge of quality engineering principals...
-
Senior Supplier Quality Engineer, NPD
2 months ago
Irvine, United States Edwards Lifesciences Full timeEdwards Lifesciences has an opportunity for a Senior Engineer, Supplier Quality on the Transcatheter Mitral and Tricuspid Therapies (TMTT) team. This cross-functional position will have a primary focus to lead in the development, improvement, maintenance, and management of suppliers. The Senior Engineer will apply knowledge of quality engineering principals...
-
Irvine, California, United States Parker Hannifin Corporation Full timePosition: Senior Quality Assurance Engineer for SuppliersLocation: United StatesDepartment: Quality AssuranceJob Type: Full-TimeCompany Overview:Parker Hannifin Corporation is a renowned leader in motion and control technologies, committed to driving engineering advancements that foster a sustainable future. As part of Parker Aerospace, we focus on...
-
Staff Quality Engineer
1 month ago
Irvine, United States BioTalent Full timeOverviewThis role is pivotal in ensuring the highest quality standards for our medical device production. The Senior Quality Engineer will be responsible for driving production quality initiatives, leading investigations, and maintaining regulatory compliance. The ideal candidate possesses a deep understanding of medical device manufacturing, quality...
-
Staff Quality Engineer
1 month ago
Irvine, United States BioTalent Full timeOverviewThis role is pivotal in ensuring the highest quality standards for our medical device production. The Senior Quality Engineer will be responsible for driving production quality initiatives, leading investigations, and maintaining regulatory compliance. The ideal candidate possesses a deep understanding of medical device manufacturing, quality...
-
Senior Quality Engineer
3 months ago
Irvine, United States Cynet Systems Inc. Full timeSkills: Creativity, verbal and written communication skills, analytical and problem-solving ability. Team player and detail-oriented. Ability to make sketches, engineering drawings, and common computations. Ability to read and interpret blueprints, technical drawings, schematics, and computer-generated reports. Previous experience with computer...
-
Supplier Quality Engineer
2 weeks ago
Irvine, United States Compunnel Inc. Full timeTop 3 required technical skills:Project & time management/organization/planningMinitab/data analysisproblem solvingNice to have skills:Inspection developmentRisk managementSolidworks/CreoSix sigmaJob Description: The Engineer will apply knowledge of quality engineering principals and methods to ensure compliance with regulatory requirements and clients...
-
Senior Substation Engineer
3 months ago
Irvine, United States 347 Group, Inc. Full timeJob DescriptionJob DescriptionWe have an immediate opportunity for a Senior Substation Engineer in Orange County. This is an excellent growth opportunity for a self-directed Electrical Engineer who is eager to take on new challenges. Duties and ResponsibilitiesResponsible for knowledge and execution of the technical aspects and deliverables of...
-
Quality Engineer
2 weeks ago
Irvine, United States Compunnel Inc. Full timeTitle: Quality EngineerPay: 50-55 USD/HR on W2Duration: 12 MonthsLocation: Irvine, CA 92614Summary: The main function of a manufacturing engineer is to apply engineering theory and principles to problems of industrial layout or manufacturing production.A typical manufacturing engineer has the ability to make engineering drawings and read and interpret...
-
Quality Engineer
7 days ago
Irvine, United States Compunnel Inc. Full timeTitle: Quality EngineerPay: 50-55 USD/HR on W2Duration: 12 MonthsLocation: Irvine, CA 92614Summary: The main function of a manufacturing engineer is to apply engineering theory and principles to problems of industrial layout or manufacturing production.A typical manufacturing engineer has the ability to make engineering drawings and read and interpret...
-
Quality Engineering Architecture Manager
2 weeks ago
Irvine, United States Hispanic Technology Executive Council Full timeQuality Engineering Architecture Manager (Accenture LLP; Irvine, CA): Accenture LLP has multiple openings for the position of Quality Engineering Architecture Manager in Irvine, CA, and the job duties are as follows: Develop or update project test plans for information technology projects, including test objectives, technologies, scope, requirements,...
-
Senior Electrical Engineer
2 months ago
Irvine, United States EVONA Full timeLocation: Irvine, California (on-site, non-negotiable)Salary: up to $200kThis Venture capital-backed New-Space Start-Up is looking for a Senior Electrical Engineer to lead the development of their camera systems from scratch.Senior Electrical Engineer ResponsibilitiesDesign and develop video-camera, compute, and storage systems, including image sensors,...
-
Senior Packaging Engineer
3 months ago
Irvine, United States Saxon Global Full timeRole : Senior Packaging Engineer Long Term contract Must have 5+ years in Medical Devices, packaging materials, testing methodologies, and cost-analysis Location: Cincinnati, OH Raritan, NJ Zuchwil, CH Boston, MA Jacksonville, FL Irvine, CA Responsibilities: Independently manage all aspects of medical device packaging projects, from...
-
Senior Electrical Engineer
4 weeks ago
Irvine, United States Bureau Veritas Full timeA WORLD LEADER IN TESTING, INSPECTION & CERTIFICATION SERVICES Bureau Veritas offers dynamic, exciting employment opportunities with an attractive salary/benefit package and an opportunity to play a vital role with a global organization. If you would enjoy working in a dynamic environment and are looking for an opportunity to become part of a stellar...
-
Senior Mechanical Engineer
4 weeks ago
Irvine, United States Bureau Veritas Full timeA WORLD LEADER IN TESTING, INSPECTION & CERTIFICATION SERVICES Bureau Veritas offers dynamic, exciting employment opportunities with an attractive salary/benefit package and an opportunity to play a vital role with a global organization. If you would enjoy working in a dynamic environment and are looking for an opportunity to become part of a stellar...
-
Lead Software Quality Assurance Engineer
5 days ago
Irvine, California, United States Talent Elite Group Full timeWe are seeking a highly skilled Senior Software Quality Assurance Engineer with a deep understanding of US FDA Quality System Regulations and ISO 13485 Design Controls. The ideal candidate will take charge of the ongoing development and management of our Quality Management System (QMS), ensuring compliance with industry standards.PRIMARY RESPONSIBILITIES:QMS...
-
Lead Software Quality Assurance Engineer
7 hours ago
Irvine, California, United States Talent Elite Group Full timeWe are looking for a highly skilled Senior Software Quality Assurance Engineer with a deep understanding of US FDA Quality System Regulations and ISO 13485 Design Controls. The ideal candidate will be responsible for the ongoing development and management of our Quality Management System (QMS), ensuring compliance with industry standards.KEY...
-
Senior Remediation Engineer
3 months ago
Irvine, United States Kennedy Jenks Full timeFounded in 1919, KJ has always looked to the future. With a talented team of professionals and a culture of continuous improvement, we deliver exceptional engineering and environmental consulting services today, with a focus on innovation and sustainability. Using new advanced analytics, technology, and tools, KJ improves designs, reduces risk, and finds...
-
Senior Project Engineer
2 weeks ago
Irvine, United States EPC STAFF Full timeEPC Staff has been approached to recruit multiple Senior Project Engineers / Assistant Project Managers for a client who have been a leader in the Southern California commercial construction space for over 60 years, with projects ranging from commercial, residential and industrial. Key Responsibilities:Assist in all phases of project management, from...
![Planet Pharma](https://media.trabajo.org/img/noimg.jpg)
Senior Quality Engineer
2 months ago
(This is a 6-month contract, with potential to convert/extend, available to candidates local to the Irvine, CA area)
Summary:
The main function of a Quality Engineer is to apply engineering theory and principles to quality issues and ensure compliance to standard procedures and regulations.
Key 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 and Edwards' systems/procedures.
- Quality Systems Engineering support, including Post-Market Quality Engineering support.
- Guide others in resolving basic issues in specialized area based on existing solutions and procedures.
- Train, coach, and guide employees on CAPA procedures.
- Other incidental duties assigned by Leadership.
Education and Experience:
- Bachelors Degree in Engineering or related field plus 4 years relative regulated industry experience required; Electrical Engineering degree preferred.
- Masters Degree will offset one (1) year of required experience.
- Working knowledge of the Domestic and International regulatory Medical Device regulations (FDA 21 CFR 820, ISO 13485; and other applicable regulatory requirements).
- 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.
Additional Skills:
- Professional level proficiency with MS Office Suite (Outlook, Word, Excel, Power Point, 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 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 established strategic goals.
- Proficient knowledge of Quality Engineering concepts relative to the level of role (Senior Engineer)
- Experience with automation, software testing, and software validation is strongly preferred.
- Must be able to work in a collaborative team environment, including inter-departmental teams and key contact 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 environment and prevention of pollution under their span of influence/control.
2 openings for this role
Pay Range: $52-58/hr *salary dependent on experience
Our client cannot accept any C2C or candidates who requires sponsorship now or at any point in the future (this includes OPT)