About this role
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob 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.
Responsibilities:
- Performance management and development of the Quality Engineering (QE)Team
- Responsible for the technical complaint process and providing technical support to both internal and external Customers when required
- Management of process and equipment performance qualifications
- QE Lead for global harmonisation projects and major equipment, process and facility changes
- Management of the Investigation process associated with Customer complaints and internal investigations.
- Monitor product quality improvement to ensure execution of actions including any resulting customer communications/interactions.
- Provide effective oversight of the execution of the Quality Plan, Risk Management activities and of all design related activities during the product/system lifecycles, including validation master plan
- Work with the global Quality Engineering, Engineering and Operations group to provide technical support for products and processes
- Execute & maintain risk assessments related to quality engineering processes
- QE process subject matter expert for external audits/visits
- Lead Auditor for internal and subject matter expert for third party audits when required.
- Develop and implement strategic plans to drive quality improvements and meet quality, health and safety, PPI and operational goals
- Ensure validation protocols and process procedures meet FDA 21CFR820 and ISO 13485 requirements
- Management of QE budget and AOP planning
- Deputy for the Site Senior Quality Manager
Minimum Requirements/Qualifications:
- Management/Leadership experience, self-motivator and drive to develop others
- Degree in a Scientific or Engineering based subject or significant experience within the Pharmaceutical/Biotech industry
- Strong knowledge of FDA 21CFR820 and ISO13485
- Experience working in a Quality or Engineering role and sound knowledge of operational processes
- Project management experience
- Qualified Lead Auditor preferably to ISO13485 standards
- Exceptional problem solving and report writing skills
- Self-assertive and able to drive new initiatives
- Excellent communication and writing skills
- Experience related to continuous improvement/lean processes
- Ability to make rational, objective and appropriate decisions relating to company & department requirements.
- Communicate recommendations and decisions across the organization.
- Experience at effectively communicating complaints, risks, production, process controls, Corrective and Preventive Action (CAPA) and improvements
- Demonstrated ability to lead in a fast-paced technical environment, absorb technical information, review technical information and make technical decisions.
- Understanding of plastics- materials, properties, manufacturing processes, and product assembly.
- Ability to analyze and process data and draw appropriate conclusions.
- Experience prioritizing conflicting demands
- Excellent interpersonal, organizational, and influencing skills
- Experience working with cross-functional teams and facilitating teams to identify and implement solutions to complex problems
Other facts
About Thermo Fisher Scientific
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 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, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team 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, Patheon and PPD.
For more information, please visit www.thermofisher.com.
What you'll do
- The Quality Engineering Manager will be responsible for the performance management and development of the Quality Engineering Team, overseeing technical complaint processes and managing process and equipment qualifications. This role also involves leading global harmonization projects and managing internal and customer-related investigations while ensuring adherence to quality plans and risk management activities.
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