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Sr Engineer

Date Posted: 2/7/2024

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Job Description

This is an exciting opportunity to work for a global leader in life-saving medical devices with a strong corporate culture and competitive pay.

Job Description: Summary:
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.
Job Responsibilities:
* 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 company' 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.

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).

All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.


To apply please email your resume to fmohammed@rothstaffing.com

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Job Snapshot

  • Employee Type:Contractor
  • Location:Irvine, CA
  • Job Type:Engineering
  • Experience:None
  • Education:None
  • Date Posted:2/7/2024
  • Contact: Farooq Mohammed (949) 620-0294
  • Pay Range: $58.00 - $61.00 Hourly
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Job Reference: JN -022024-358349