Work ScheduleStandard (Mon-Fri)Environmental ConditionsAdherence to all Good Manufacturing Practices (GMP) Safety Standards, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Various outside weather conditionsJob DescriptionAs part of the Thermo Fisher Scientific team, you’ll discover meaningful work that positively impacts a global scale. Join our colleagues in bringing our Mission to life daily 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, ensuring our food is safe, or helping find cures for cancer.We are looking for a forward-thinking quality assurance manager who can lead the quality function at our site in Mebane, North Carolina! This key leadership position is accountable for improving product and process quality, developing, sustaining, and improving the quality management system, and leading customer expectations. The person in this position is also responsible for structuring and developing the QA team in support of business growth while creating a culture where everyone owns quality.A Day in the Life:
Sets the overall quality strategy for the Mebane manufacturing site that supports growth and compliance readiness.
Actively participates in quality improvement projects.
Provides leadership and coaching to Operations Quality, Quality Systems, and Technical Quality/Quality Engineering teams.
Leads maintains and creates efficiencies in the Quality Management System to fulfill international quality system requirements (e.g., 21 CFR 820, ISO 9001, ISO 13485, and IVDR), as applicable.
Assures management reviews of the quality system are held and properly documented to reflect the status of the quality system's effectiveness and the resulting corrective actions and improvement plans/actions.
Works closely with all staff to ensure that all aspects of the QMS are understood, implemented, and maintained.
Builds cross-functional partnerships and influences all business functions to apply appropriate quality tools, including Lean, Six Sigma, TQM principles, business process improvement methods, and statistical methods (e.g., experiment design, statistical process control).
Maintains alliance with Divisional, Group, and corporate Quality and Regulatory Affairs to ensure participation in and understanding of associated initiatives.
Effectively leads Corrective and Preventive Action Systems. Works with various departments to identify actions required to ensure corrective and preventative actions are properly documented and follows up to initiate and monitor the timely completion of actions.
Supervises the Internal Audit program, assuring compliance with regulatory standards. Coordinates and participates in any external or customer audits.
Sets site-wide QA/QC priorities and key objectives to reduce the cost of poor quality and improve compliance with regulations and the site Quality System.
Leads Key Quality Business Metrics and Department Metrics.
Acts as the site quality representative for third-party, regulatory, and government agencies.
Other duties may be assigned.
Keys to Success:Education
Bachelor's Degree in Engineering or a similar technical field is required.
Experience
8+ years of quality experience required.
1+ years of leadership experience preferred.
Experience in plastic injection, pharma, biotech, and medical device industries is highly preferred.
Knowledge, Skills, Abilities
Knowledge of ISO 13485 or 9001, good manufacturing practices, Excel, Word, Access, quality software and statistical methods (SPC, DOE, etc.).
This position does not offer relocation benefits.Benefits:We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!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. We will gladly provide reasonable accommodations covered under the ADA.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.