wwwLathaHR.com Looking for Mechanical Engineer with CAPA experience, Irvine, CA

Please send profiles to rani@horizonsoftech.net

 

Hi,          

 

Please let me know if you are comfortable with the below position.

 

Role :- Mechanical Engineer with CAPA experience

Location  :- Irvine, CA

Duration  :- 12 Months

Start Date  : - ASAP

 

1. Formal Mechanical Engineering Degree. Masters would be a plus

2. 10 - 12 years of experience of which at least 5 years of extensive experience working on CAPA's for Medical devices industry. Working on R&D related CAPA would be a plus

3. PMP certified

4. Experience in working on MPP.

 Job description:

·         Act as Syntel's Single Point of Contact (SPOC) for the client.

·         Proactively communicate project status, issues & risk to management.

·         Provides leadership and direction, championing departmental or cross-functional CAPA initiatives.

·         Responsible for the overall direction, coordination and evaluation of the CAPA process.

·         Use technical/compliance information to guide and influence CAPA Compliance strategies.

·         Responsible for planning, assigning, directing work; addressing CAPA issues and resolving problems.

·         Facilitate discussions with CAPA owners to drive completion of investigations, root-cause analysis, impact analysis, and closure of CAPAs.

·         Monitor investigations and approvals to ensure that all the required information is captured and documented with relation to CAPA.

·         Drive timely execution of CAPA deliverables through monitoring and reporting status to CAPA owners and management.

·         Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving CAPA.

·         Analyze trends to monitor the effectiveness of the CAPA process and drive remediation for improvement.

·         Provide technical writing support for CAPA projects.

·         Maintains compliance to FDA Quality System Regulation, MDD, ISO 9001 or ISO 13485 (current revisions).

 

  

Thanks & Regards

Rani

IT  Recruiter

Ph:248-275-1810,Fax: 313-397-0860

Email:rani@horizonsoftech.net    

www.horizonsoftech.net

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