Engineer III, QA
Thermo Fisher Scientific

Job Info

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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

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