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.

Location/Division Specific Information

This role is based in Logan, UT, USA, within the Single Use Division of Thermo Fisher Scientific Inc.

Discover Impactful Work:
The Manager of Quality Engineering drives day-to-day activities within and is responsible for the resolution of issues with customers (internal and external) and suppliers that relate to quality.  Providing the structure and tools necessary to assure consistency and ongoing improvement of products and services in addition to compliance with customer and regulatory requirements. 

A Day in the Life:

Lead a team of Quality Engineers responsible for investigating customer complaints & internal investigations, process validation program, and new product development projectsMonitor product quality improvement to ensure execution of actions including any resulting customer communications/interactions.Establish & maintain quality metrics to measure progress against goals related to complaint execution, process validation, and new product developmentExecute & maintain risk assessments related to quality engineering processesProvide 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 planInteract directly with customers and internal groupsOptimally use continuous improvement skills and tools to prioritize and drive projects and improvements/standardization across the network to improve Quality service levels, reduce costs, and align with strategic objectives.Coach and support team members through their technical and professional developmentCommunicate effectively both within immediate quality teams and across network and division leadershipHelp sites prepare for, and actively support, external audits (customer & regulatory) ensuring corrective/preventative actions are put in place to address identified non-conformances.Provide leadership to the quality function vital to ensure that strategic and annual quality planning is integrated into strategic and operating plans with broad-based interpersonal involvement.Ensures participation in New Product Development Process. Assures new product quality requirements are met before product launch.

Education:

Minimum Education Required: Bachelor’s degree (or higher) in an engineering, science, operations or related field

Experience:

8+ years of professional experience in an Engineering, Quality or Operations related role3+ years’ experience as people managerExperience related to continuous improvement/lean processesExperience with presenting complaints, risks, production, process controls, Corrective and Preventive Action (CAPA) and improvementsExperience working with cross-functional teams and facilitating teams to identify and implement solutions to complex problemsWorking experience with cGMP requirements (21 CFR 820)Prior med device, ISO 13485, or single use experience preferred.

Knowledge, Skills, Abilities

Ability to manage & implement changes with minimal supervision, onsite and remotely at global locations. Must be able to influence & negotiate with people & resolve issues.  Ability to make rational, objective and appropriate decisions relating to company & department requirements.  Ability to identify customer needs and issues.Communicate recommendation and decisions across the organization. Demonstrated knowledge of Quality Management System tools, continuous improvement methodologies, in-depth understanding of products and processesProven 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.Strong communication and writing skills.Excellent communication and presentation skills. Proficient with Microsoft tools; Word, Excel, Power Point.Excellent interpersonal, organizational, and influencing skillsAbility to analyze and process data, and draw the appropriate conclusions

Physical Requirements / Work Environment

Work may include occasional physical tasks such as lifting and extended periods of standing. The role necessitates strict alignment to safety guidelines in a dynamic and collaborative work setting.