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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