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CAPA facilitator


Intelliswift Software


Location

Pune | India


Job description

Hello Everyone..

We are Hiring for our Product base company to the permanent position for CAPA Facilitator with 8-10 Yrs Experience with immediate joiners only for Bangalore.

Company Description :

Intelliswift Software delivers Product Engineering, Data Management and Analytics, Digital Enterprise, Digital Integration, Salesforce, and Talent Solutions to businesses across the globe, with strong customer-centricity. We serve industries ranging from Technology to Healthcare and are driven to create a long-lasting impact for our customers and stakeholders through sustainable and innovative solutions.

Skill: CAPA Facilitator

Description:

You are responsible for

• Supporting CAPA activities: assessing complex investigations and corrective actions, reviewing test and other complex performance data, leading complex root cause analysis and quality problem solving

• Facilitate product and process CAPA investigations from issue identification through implementation of solution and effectiveness monitoring

• Support CAPA Owner in all aspects of CAPA activity which includes gaining the commitment of cross functional resources, scheduling CAPA team meetings, and ensuring CAPA deliverables per project timelines

• Support CAPA Owners in the presentation of CAPAs during audits and CAPA Review Board meetings

• Mentor cross functional teams with the implementation of appropriate root cause analysis techniques

• Mentor the analyze of quality monitoring data sources and apply statistical techniques to identify existing and potential causes of non-conformances

You are a part of

Our Quality & Regulatory organization, supporting the Diagnostic X-Ray Business .

To succeed in this role, you'll need a customer-first attitude and the following

• B.Sc in Engineering or other relevant academic field as statistics, quality management, etc., advanced degrees – an advantage

5+ years' experience in quality roles in medical device or other regulated industry

• Working knowledge of appropriate global regulations, requirements, and standards such as 21 CFR Parts 803, 806, and 820, ISO 13485, and ISO 9001, and ISO 14971

• Good understanding of statistical methods, quality tools, problem solving tools and methodologies (i.e. 8D, DMAIC, SPC, FMEA, Control Plan, LEAN) – an advantage

• Experience as team facilitator / team coach

• Work experience in complex organizations with Manufacturing, R&D and Engineering environments

• Strong communication and interpersonal skills, ability to coach teams in matrix environment cross-functional teams

• Strong technical writing skills

• Ability to resolve complex issues in creative ways and influence stakeholders accordingly

• Multi-tasking and decision-making capabilities

• Self-starter, motivated, action-oriented

• Experience working in global corporate environment

• Fluent English

Anyone interested for the above opportunity kinldy share resume for the below mail ID.

[HIDDEN TEXT].

Regards

Priya

[HIDDEN TEXT]


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