Quality Manager

Thermo Fisher Scientific•Eugene, OR

14d•Onsite

About The Position

At Thermo Fisher Scientific, you’ll discover impactful work, innovative thinking, and a dedication to working the right way, for the right reasons - with the customer always top of mind. The work we do matters, like helping customers find cures for cancer, develop new scientific knowledge, and deliver COVID-19 solutions. As the world leader in serving science, with the largest investment in R&D in the industry, our colleagues are empowered to realize their full potential as part of a fast-growing, global organization that values passion and outstanding contributions. Our commitment to our colleagues across the globe is to provide the resources and opportunities they need to make a difference in our world while building an exciting career with us. Our manufacturing site in Eugene, Oregon partners with research, medical device, pharmaceutical, and biotech customers around the world to further life science research that makes the world healthier, cleaner, and safer. Discover Impactful Work: As part of our team, what you do contributes directly to our Mission: to enable our customers to make the world healthier, cleaner, and safer.

Requirements

Bachelor’s Degree in a related scientific field
5 years of proven experience in a manufacturing environment with a minimum experience of 2 years in Quality Assurance.
2 years of supervisory experience or equivalent, required
Knowledge of and direct experience working with ISO standards, required
Strong written and oral communication skills that deliver effective communication for multiple levels of staff
Strong risk management and problem-solving skills
Meticulous, organized and accurate documentation
Accurate and efficient work in an environment that may change frequently
Demonstrated excellent analytical, judgment, decision and discretion abilities
Excellent leadership, program and project management skills
Ability to influence others and drive and prioritize results
Experience mentoring and creating development opportunities for staff
Must be comfortable with decision-making on diversified issues and interacting with customers on a routine basis.

Nice To Haves

Experience collaborating with customers and Regulatory bodies, preferred

Responsibilities

Coordinate all Quality Assurance and Control functions for the site.
Supervise the development, implementation and maintenance of quality management systems and quality control.
Ensure company activities and systems remain in constant compliance with both company quality standards and applicable regulations.
Create an environment that encourages and promotes adherence to Quality Assurance policies and requirements.
Maintain and guide compliance to ISO 13485 and ISO 9001 standards.
Manage Quality Assurance and Control personnel in a manufacturing environment.
Report to top management on the performance of the quality management system and improvement needs, including through scheduled Management Reviews.
Promote awareness of customer requirements throughout the organization.
Represent management during certification and surveillance audits.
Communicate to the Top Management on Quality issues / Non-conformities & Audit reports.
Oversee the planning and execution of internal and customer audits.
Align with Operations and site Managers to resolve quality issues and customer complaints.
Manage Quality training system for new associates.
Oversee incoming inspection of raw materials.
Oversee document control activities and the metrology program.
Lead and participate in cross functional teams for new product development, technology transfers, process improvements and general operations.
Perform all job duties in a safe manner and obey all safety policies.
Perform all job duties consistent with the Code of Ethics and the 4-I values.
Perform all job duties within ISO standards, regulatory and statutory requirements.
Perform other duties as assigned.