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.

Responsibilities:

Performance management and development of the Quality Engineering (QE)TeamResponsible for the technical complaint process and providing technical support to both internal and external Customers when requiredManagement of process and equipment performance qualificationsQE Lead for global harmonisation projects and major equipment, process and facility changesManagement 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 planWork with the global Quality Engineering, Engineering and Operations group to provide technical support for products and processesExecute & maintain risk assessments related to quality engineering processesQE process subject matter expert for external audits/visitsLead 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 goalsEnsure validation protocols and process procedures meet FDA 21CFR820 and ISO 13485 requirementsManagement of QE budget and AOP planningDeputy for the Site Senior Quality Manager

Minimum Requirements/Qualifications:

Management/Leadership experience, self-motivator and drive to develop othersDegree in a Scientific or Engineering based subject or significant experience within the Pharmaceutical/Biotech industryStrong knowledge of FDA 21CFR820 and ISO13485Experience working in a Quality or Engineering role and sound knowledge of operational processesProject management experienceQualified Lead Auditor preferably to ISO13485 standardsExceptional problem solving and report writing skillsSelf-assertive and able to drive new initiativesExcellent communication and writing skillsExperience related to continuous improvement/lean processesAbility 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 improvementsDemonstrated 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 demandsExcellent interpersonal, organizational, and influencing skillsExperience working with cross-functional teams and facilitating teams to identify and implement solutions to complex problems