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.
This position leads the Quality function in the Marietta, Ohio facility and is a member of the Site Leadership Team! The successful candidate for this role will be responsible for working with the site to develop and deploy a world class quality and compliance strategic plan that applies Lean, Continuous Improvement and Statistical Process Control to deliver high quality temperature control products to our customers. The ability to build a rapport with all colleagues at the site is important in order to lead a culture of compliance across the site. The ability and desire to mentor early career colleagues in accurate root cause investigations, process validations and compliance systems is also needed.
What will you do?
Maintain a Quality Organization by anticipating and identifying customer needs and priorities and integrating them into the Quality System
Ensure the site maintains continued compliance to ISO 13485, 21CFR820, EU MDR, Customer Requirements and others as necessary
Establish goals and objectives that stretch boundaries by detailing specific continuous improvement activities focused on enhancing internal process and test yields
Interact with Customers and Suppliers, when required, to promote external relationships or resolve opportunities.
Promote LEAN Enterprise approaches with a quality principled focus that includes Daily Standard Work and continuous focus on processes.
Create and maintain both a Quality-centric and Quality-focused culture for all production activities
Perform all job duties in a safe manner and obey all safety policies and procedures
Perform as a Role Model Leader, acting in compliance with the Thermo Fisher Code of Ethics and the 4-I Values (Integrity, Intensity, Involvement and Innovation).
Perform other duties and cross training as assigned
Education:
Bachelor Degree required, a degree in Engineering, Quality Management, Bio-medical or related field is preferred.Experience:
8+ of experience in dynamic roles with manufacturing companies producing electro-mechanical products
3+ years experience in a leadership role
Regulatory experience in International Standards ISO-13485:2016, EU MDR and 21 Code of Federal Regulations (CFR) Part 820 Food and Drug Administration (FDA) Quality Systems Regulation (QSR) is preferred
Excellent planning, organizational and communications skills.
Experience in leading teams in the implementation of quality improvements systems resulting in reduced cost and cycle times with improved quality of products and services
Knowledge, Skills, Abilities:
Effective presentation skills to communicate to all levels on issues that include Quality Plans and Quality Management Systems, performance metrics and improvement systems
Able to travel (domestic and international) up to 10%
Physical Demands:
Ability to sit at a computer workstation in an office environment
Ability to frequently walk, sit, talk, hear, smell and see/distinguish color
Ability to climb and descend stairs, stand, bend, stretch, reach and kneel while intermittently being exposed to noise, fumes, dust and dirt while in manufacturing area
Ability to occasionally lift up to 40 pounds
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one global team of 100,000 colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
Apply today! http://jobs.thermofisher.com
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.
Accessibility/Disability Access
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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.