Quality Systems Specialist
- Thermo Fisher
- 8 - 11 Years
- Hyderabad
- 3 years ago
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Job Description
Job Description :
Responsibilities :
- Responsible for Quality Management System maintenance, monitoring and continuous improvement
- Responsible to increase awareness, visibility, and communication on Quality Management Initiatives to support the organization's Quality goals.
- Responsible for review of and adherence to quality parameters as defined in the Quality Management System
- Assist in measurement, analysis and improvement efforts including Corrective and Preventive Actions (CAPA) as defined in the Quality management system
- Provide and/or facilitate internal training on Quality Management System requirements and ensure adoption throughout the organization
- Coordinate Internal and/or Notified (external) Body audits and author quality system audit reports
- Facilitate investigation of customer complaints, perform root cause analysis and evaluate mitigations
- Coordinate Management Review meetings and collate information for leadership presentations
- Draft and execute Quality Agreements with internal and external partners Maintain a repository of technical files, design history files and reports of product conformity and manage the Document Control System
- Support and assist in change management activities
Qualification & Experience
- Graduate degree
- At least 8 years experience in Quality Assurance with a minimum of 3years in managing Quality systems.
- Experience within Medical Device or any regulated industry will be preferred
- Medical Device manufacturing experience will be preferred
- Six Sigma certification will be preferred
Skills, Knowledge, and Experience
- Working knowledge of the application of FDA and/or ISO quality standards in the industry.
- Experience with FDA or Notified Body audits/inspections.
- Analytical and structured working style strong attention to detail
- Fluency in written and spoken English is mandatory
- Adaptability and flexibility to manage changing demands and handle substantial time pressures
- A proven facilitator with good influencing skills who effectively coordinates and leads efforts and input from various internal functional groups, which will result in collective team achievements
Employement Category:
Employement Type: Full timeIndustry: Bio Technology & Life Sciences
Functional Area: Operations
Role Category: Flexibility
Role/Responsibilies: Quality Systems Specialist
Contact Details:
Company: Thermo FisherLocation(s): Hyderabad
Keyskills: Flexibility analytical Quality Systems preventive actions customer complaints Quality Managemen Continuous Improvemen english Training Leadership Facilitator Six Sigma Influencing management review english is Responsible
Thermo Fisher
When you join us at Thermo Fisher Scientific, you will be part of a smart, driven team that shares your passion for exploration and discovery. With revenues of $20 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contri...
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