320 Senior Quality Engineer Jobs in Irvine, CA
intellectt is Hiring a Senior Quality Engineer Near Irvine, CA
Location: Irvine, CA - 92614
Duration: 12 Months
Job Description
- The Senior Quality Engineer will focus on providing ownership and support of all phases of the CAPA process including investigations, robust root cause analysis, development and implementation of corrective actions, and effectiveness monitoring and will interact with the CC global manufacturing sites.
- Manage end to end CAPA process with the support of SMEs from a cross functional team. 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.
- 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.
- Working knowledge and understanding of statistical techniques.
- Ability to read and interpret drawings.
- Ability to prioritize, plan & evaluate deliverables to established 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 contact for internal and outside customers.
- Bachelor's degree in engineering required.
- 5-7 years experience required.
- Working knowledge of the Domestic and International regulatory Medical Device regulations (FDA 21 CFR 820, ISO 13485; and other applicable regulatory requirements).
Job Summary
Contractor
Business Services
$96k-115k (estimate)
06/05/2024
08/06/2024
intellectt.com
ISELIN, NJ
200 - 500
2018
KIRAN MADALA
$5M - $10M
Business Services
Related Companies
About intellectt
Intellectt Inc. was founded to set a new standard in Consulting and Staffing Industry. Our company is made up of dreamers, calculated risk-takers, diligent people that go to fight for the brand of our client. Intellectt Inc. and our affiliated brands provide innovative talent solutions that make our clients businesses better. Our verticals include Healthcare and IT. We exist to become the finest and most esteemed staffing company across the USA and we look forward to putting our talents to use to push your organization forward.
The job skills required for Senior Quality Engineer include ISO, Product Quality, Root Cause Analysis, etc. Having related job skills and expertise will give you an advantage when applying to be a Senior Quality Engineer. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Senior Quality Engineer. Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for Senior Quality Engineer positions, which can be used as a reference in future career path planning. As a Senior Quality Engineer, it can be promoted into senior positions as a Quality Assurance Engineer III that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Senior Quality Engineer. You can explore the career advancement for a Senior Quality Engineer below and select your interested title to get hiring information.
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