Quality Manager

Work Schedule

Environmental Conditions

Job Description

At Thermo Fisher Scientific team, 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.

Location/Division Specific Information

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.

What will you do?

The Quality Manager will:

• 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. 

This customer-facing role will require excellent communication skills in addition to attention to detail and a strong drive for action.

How will you get there?

• 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

Responsibilities

• 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

Knowledge, Skills, Abilities

• 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
• Experience collaborating with customers and Regulatory bodies, preferred
• Must be comfortable with decision-making on diversified issues and interacting with customers on a routine basis.

Physical Requirements

• This role is positioned in a warehouse/manufacturing environment and requires standing, sitting, walking and talking.
• Must be able to work in an environment in which numerous chemicals are processed and packaged.

Our Mission is to enable our customers to make the world healthier, cleaner and safer. As one 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, and drive technological innovation. #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

Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.

*This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.