Engineer III, QA
Company: Thermo Fisher Scientific
Location: Greencastle
Posted on: April 20, 2024
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Job Description:
Job Description
At Thermo Fisher Scientific, our Quality teams are important to our
business and functional teams to make educated, sound decisions
that drive our Mission and make us a stable and trusted industry
leader. From Quality Assurance to Quality Control and Quality
Engineering, our Quality functions have a diverse and global
presence, providing significant opportunities to develop
outstanding career experiences and perspectives. Ranked #95 on the
2021 Fortune 500 list and with revenues of more than $40 billion,
you'll discover endless opportunities to grow a rewarding career as
part of the world leader serving science!
Position: Quality Engineer III
Location: US - Greencastle, PA
How you will make an impact
If you have a passion for Quality across a global, multi-faceted
organization, Thermo Fisher Scientific's Quality Assurance function
is the team for you. With a keen understanding of applicable
legislation, regulations, and compliance this team uses innovative
systems and controls, and robust processes to protect the company's
assets and support its short- and long-term growth on a global
scale.
This role supports our Distribution Center and is primarily
office-based. Essential functions include support of the Quality
Management System (QMS), key member of the site Quality Team, CAPA,
Change Control, Risk Assessments & Data Integrity.
In addition, the position holder will identify and recommend
operational improvement opportunities and support leadership in
achieving of business objectives.
What will you do?
Responsible for Quality-related activities at the Greencastle
Distribution Center
Further establish and enhance all aspects of the Quality Management
System from strategic planning to hands-on implementation on topics
such as Distribution Quality Assurance, auditing, document
management, CAPA resolution.
Maintain working knowledge of Regulatory and Quality System
requirements (ISO 13485/FDA CFR)
Cultivate a partnership with Operations to drive a culture of
continuous education of the Quality Management System
Implement a "Problem Solving" approach to Quality issues that will
drive sustainable Root Cause and Corrective Action.
Drive continuous improvement across the Distribution Quality
function, including a focus on reducing customer complaints.
Champion the CAPA database system and ensure robust
corrective/preventive actions are established and effective in a
timely manner working with multi-functional teams
Provide Quality guidance to product-related investigations,
deviations, change controls, validation protocols, validation
reports, and SOPs.
Manage the Change Control System and perform Risk Assessments
Provide training and support to other QA staff as required as well
as other departments within Distribution to help build an engaged
and involved team who work effectively together to meet the
department/site goals and KPIs
Facilitating & participate in Customer/Internal audits
Utilise and be responsible for the Trackwise system -
non-conformances, deviations, CAPA
Utilise problem-solving skills related to quality issues ensuring
timely resolution for minimal impact.
Embrace site PPI initiatives and adopt this methodology in
day-to-day tasks
Perform daily Good Distribution Practices checks and
enforcement.
May be required to work in a warehouse environment under various
temperatures including room temperature (59-86 degrees F),
cold-room (36-46 degrees F), and/or freezer-room (minus 4 - 23
degrees F).
May be required to routinely push and pull and/or lift up to 40 lbs
(20 kg).
May be required to perform other related duties as required and/or
assigned
How you will get here
Education
Bachelor's degree preferred. Will consider applicable
experience.
Experience
5 years of experience administering quality systems such as change
control, CAPA, training.
Knowledge and direct experience working with ISO 13485
3 years of experience as a people leader-preferred
Knowledge, Skills, Abilities
Communicate effectively with multiple levels of staff throughout
the organization
Possess strong organizational skills to manage and prioritize
multiple tasks
Thorough and accurate
Successful with influencing and driving results
Self-motivated with the ability to work as part of a team and/or
independently
Travel requirements
Less than 25% domestic/international travel required
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.
We will ensure that individuals with disabilities are provided
reasonable accommodation to participate in the job application or
interview process, to perform essential job functions, and to
receive other benefits and privileges of employment. Please contact
us to request accommodation
At Thermo Fisher Scientific, each one of our 100,000 extraordinary
minds has a unique story to tell. Join us and contribute to our
singular mission-enabling our customers to make the world
healthier, cleaner and safer
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, Frederick , Engineer III, QA, Engineering , Greencastle, Maryland
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