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Director of Quality- Laboratory Equipment

Company: Thermo Fisher Scientific
Location: Tallahassee
Posted on: September 23, 2022

Job Description:

At Thermo Fisher Scientific team, you'll discover impactful work, innovative thinking and a culture dedicated 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, protecting the environment, making sure our food is safe and delivering 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 unique 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 a fulfilling career with us.

**Location/Division Specific Information**

Director, Quality, Laboratory Equipment, Laboratory Products Division, Asheville, NC

Discover Impactful Work:

A day in the Life:

+ Leads the Quality organization of approximately 100 team members across 7 sites, supporting the development, manufacture and lifecycle management of our laboratory equipment product lines which include Class I medical devices.

+ Assures the Quality Management System is implemented and in conformance to global regulatory requirements and standards.

+ Responsible for leading regulatory agency and certification body audit strategies across the division and supporting functions.

+ Applies quality statistics to develop effective strategies to improve the performance of the quality system. Develops relationships with key development and manufacturing clients to identify emerging needs. Resolves complex problems that have implications beyond own area.

+ Leads projects with a minimum supervision; may lead multiple projects, including running project timelines and results. Leads implementation of new methodologies and processes. Liaises with internal scientific, analytical, manufacturing and laboratory functional areas to meet project and team objectives.

+ Partners with business, operations, R&D, technical/field service and other cross-functional teams to establish strategic quality initiatives, performance metrics, and continuous improvement targets, and to define roles/responsibilities associated with these programs.

+ Champions Quality by Design through the application of design controls, statistical process control, practical process improvement and other tools which support QMS compliance and advancement.

+ Serves as a member of the Life Sciences and Laboratory Products Group, Quality and Regulatory Affairs Leadership team, responsible for the global strategic operation of the organization in support of the LSLPG business.

+ Participates and provides expertise as a member of the Customer Service Departmental Team. The team's objectives are to develop and recommend changes to existing methods and systems to increase the accuracy, efficiency, and responsiveness of the Customer Service Department as a whole

Keys to Success:

**Education**

+ Bachelors Degree in Engineering or Science

**Experience**

+ Minimum of 10 years in a regulated medical device manufacturing company, including minimum of 5 years leading a quality organization responsible for QA/QC, CAPA, post-market surveillance and all facets of product quality in a hardware/equipment medical device manufacturing site.

+ Demonstrate a working understanding of applicable global medical device regulations and standards, (21 CFR Part 820, ISO13485, EU 2017/745 MDR, risk management ISO14971, and other relevant global standards), design control principles.

+ Candidate will possess a strong process improvement background. Experience with use of statistical process control and statistical problem-solving methods, including Six-Sigma methods is preferred.

**Knowledge, Skills, Abilities**

+ Electromechanical equipment manufacturing/quality assurance skills.

+ Lean, Six Sigma principles and improvement systems.

+ Experience in dealing with representatives from Food and Drug Administration or other regulatory agencies.

+ Quality Engineering Certification (ASQ) a plus

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 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

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.

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.

Keywords: Thermo Fisher Scientific, Tallahassee , Director of Quality- Laboratory Equipment, Healthcare , Tallahassee, Florida

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