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Manager, Quality Systems

12 years

Andhra pradesh

Posted:8 months ago

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Job Description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
DESCRIPTION: As a Quality Manager at Thermo Fisher Scientific, you will contribute to excellence across our quality management systems while enabling our mission to make the world healthier, cleaner and safer. You will guide quality initiatives, support continuous improvement, and cultivate a culture of compliance and operational excellence. Working collaboratively across functions, you will ensure adherence to regulatory requirements while maintaining the highest quality standards for our products and services. This role offers the opportunity to make a meaningful impact by protecting patient safety, supporting innovative research, and enabling critical scientific discoveries. REQUIREMENTS:
  • Advanced Degree plus 12 years of experience, or Bachelor's Degree plus 15 years of experience in quality experience in pharmaceutical, medical device or regulated industry
  • Preferred Fields of Study: Chemistry, Biology, Engineering, Pharmacy, or related scientific/technical field
  • Lead Auditor certification in ISO 13485/9001 preferred
  • 3-5 years of leadership/management experience
  • Comprehensive knowledge of quality management systems and regulations (ISO 9001, ISO 13485, FDA QSR/cGMP, NABL/ISO 17025)
  • Strong understanding of quality tools and methodologies (CAPA, risk analysis, FMEA, root cause analysis)
  • Experience leading internal/external audits and regulatory inspections
  • Demonstrated ability to develop and mentor quality teams
  • Successful experience implementing and improving quality systems
  • Skill in cross-functional collaboration and stakeholder management
  • Strong analytical and problem-solving capabilities
  • Clear written and verbal communication skills
  • Proficiency with quality management software (TrackWise, Document Control Systems)
  • Experience with continuous improvement methodologies (Lean, Six Sigma)
  • Ability to promote quality culture across all levels
  • Focus on customer needs and ability to manage customer/supplier relationships
  • Project management experience preferred
  • Up to 20% travel may be required

Skills Required

management support compliance research engineering certification leadership regulations risk analysis fmea audits collaboration communication software trackwise lean

Work Mode

On-site

Job Type

Part Time

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Thermo Fisher Scientific

Healthcare/Scientific Instruments

Waltham

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