When you're part of the team at Thermo Fisher Scientific, you'll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you'll be supported in achieving your career goals.
The Quality Manager is responsible for the leadership of the Quality Management Systems in support of the site quality programs, processes and activities which best utilize quality resources to support the reliability and quality of our products and meet the demands of customers. This position is responsible for site quality related activities including Quality Assurance, Supplier Quality, Final & Incoming Inspection and Documentation Control.
- Manage the activities of the Quality Organization to ensure compliance with manufacturing standards and product claims
- Ensure compliance to ISO 9001:2015
- Design, implement and maintain quality assurance systems in compliance with ISO9001 and customer requirements to promote the highest standards for product quality and reliability, including:
- Internal audit process
- Corrective action programs (internal and supplier focused)
- Material Review Board
- Customer Complaint Process
- Document Control / ECO / ECR System
- Incoming Inspection & Final Product Release
- Change control for documents and manufacturing processes
- Training on Quality procedures
- Partner with site leadership to implement and manage effective process control improvement activities through the monitoring of metrics, the development and completion of initiatives, and auditing as required to assure that quality requirements are met.
- Create, review and revise quality policies and procedures to ensure effectiveness
- Represent the site in QMS audits, continuous improvement activities and supplier quality initiatives.
- Analyze non-conformance and other production data to identify and prioritize CAPA opportunities or specification and/or process improvements.
- Act as the main quality stakeholder in development programs, setting the quality requirements to assure new product introduction (NPI) processes and concurrent engineering methods are robust resulting in minimum time to market and high quality product launch. Act as reviewer in areas where others set the requirements
- Engage with suppliers and purchasing group in monitoring supplier quality performance and continuous improvement activities.
- Respond to customer requests, complaints and surveys as needed.
- Perform all job duties consistent with the Thermo Fisher Scientific Code of Ethics and the 4-I values
- Provide daily direction and priorities for the site Quality Assurance staff
- Assure that issues potentially affecting product quality/compliance are brought to the attention of Senior Management.
- Other related duties as assigned.
- BA/BS degree in Engineering, Quality and/or related technical degree preferred.
- Minimum of 8 years progressive experience in quality roles with proven results demonstrating bottom-line performance impact.
- Must have successfully led teams in a manufacturing environment. Must have demonstrated people management and employee development skills for direct and indirect reports in a fast-paced, quality-focused manufacturing or production environment.
- Mechanical Assembly and test experience preferred
- Six-Sigma certification a plus.
- Expert knowledge in ISO9001:2015 and industry specific standards.
- Committed and self-driven with a positive mindset, flexible and persistence
- Strong critical thinking skills with attention to detail without losing the greater picture
- Proven leadership skills with the ability to influence and negotiate across all levels of the organization;
- Knowledge and experience with lean manufacturing principles, DOE, Process/Design FMEA
This position does NOT have relocation assistance.
At Thermo Fisher Scientific, each one of our 55,000 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.
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.