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Senior Quality Engineer- CAPA
intellectt Irvine, CA
$98k-117k (estimate)
Contractor | Business Services 3 Weeks Ago
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intellectt is Hiring a Senior Quality Engineer- CAPA Near Irvine, CA

Hello,
I Hope you are doing great.
This is Bhanu from Intellectt INC; we’ve got an important role Senior Quality Engineer - Irvine, CA with one of our prestigious clients. Interested candidates can please send your updated resume at bhanu@intellectt.com
Role: Senior Quality EngineerLocation: Irvine, CADuration: 12 MonthsSummaryJob 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 procedures.
  • 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.
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.
  • 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)
  • Must be able to work in a collaborative team environment, including inter-departmental teams and key contact for internal and outside customers.
Education/Experience
  • 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).
Thanks & Regards,
Ajay BhanuIntellectt Inc
Direct: 732 784 4384Desk number : 732 412 6999- Ext: 159
517 Route 1 South, Suite 1115 Iselin, NJ 08830
WhatsApp: https://chatwith.io/s/bhanu

Job Summary

JOB TYPE

Contractor

INDUSTRY

Business Services

SALARY

$98k-117k (estimate)

POST DATE

06/05/2024

EXPIRATION DATE

08/06/2024

WEBSITE

intellectt.com

HEADQUARTERS

ISELIN, NJ

SIZE

200 - 500

FOUNDED

2018

CEO

KIRAN MADALA

REVENUE

$5M - $10M

INDUSTRY

Business Services

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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.

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