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How Will You Make an Impact?
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $30 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 80,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.
As the Senior Manager, Quality Assurance you will collaborate with cross-functional teams to manage product quality function in overall systems and drive quality initiatives to achieve continual quality improvement objectives
What will you do?
  • Support and assist HOD on the operation’s ISO 9001, ISO 13485, ISO14001, ISO45001 and WHO Good Distribution Practice certification and FDA 21 CFR part 820 compliance by providing leadership and coordinating different functional activities.
  • Responsible for Site Quality Compliance initiatives and programs align with Global and BU Quality targets.
  • Support and assist HOD to review, develop and implementation of all quality policies and procedures to ensure product conformity with corporate specifications, government and industry standards.
  • Support and assist HOD for site initiatives and programs under Corporate Quality and review performance timely. Manage quality and compliance metrics with target and corporate initiatives that will result in overall effectiveness to the organization.
  • Manage field response rate and ensure corrective actions are implemented throughout manufacturing site. Responsible for communication on Quality issues and Quality/Product Regulatory compliance issues with external and other compliance authorities/ parties.
  • Responsible for Products Quality to conform to specifications.
  • Support and assist HOD in reporting to executive management for the Quality performance for QMS, Quality performance, Non-conformities & Audit results and needs for improvement through PPI initiatives.
  • Ensuring the promotion of awareness of customer requirements throughout the organization.
  • Support and Assist HOD to develop and review talents gaps within the Quality organization.
How will you get here?
Education
  • Bachelor’s Degree in Engineering or Sciences
Experience
  • Exposure in manufacturing of medical instruments/IVD/Regulated Products
  • Handled and organized FDA inspections
  • Work in a Quality Assurance Function of which 8 years must be in a management role
  • Minimum 10 years of working experience in Regulated Medical Device Industry
Knowledge, Skills, Abilities
  • A good team player and an exemplary leader.
  • Able to manage in a global matrix organization environment.
  • Ability to handle uncertainty and mitigate risk.
  • Able to think strategically, creatively and rationally.
  • Strong communication (verbal and written) and good interpersonal skills with all levels.
  • Strong planning, negotiation & organizing skills.
At Thermo Fisher Scientific, each one of our 80,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer. Apply today http://jobs.thermofisher.com
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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