Engineer II, QA

Work Schedule

Environmental Conditions

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

Located in Marietta, OH, at 401 Millcreek Road. Join the Laboratory Products Division, aiding life sciences research and global quality of life.

How Will You Make an Impact?

Join Thermo Fisher Scientific’s Quality Assurance team and make a difference in a global, dynamic organization. Your role will be important in ensuring flawless quality and compliance, supporting our mission to drive growth and innovation.

• Knowledge of Regulatory and Quality system requirements (ISO 13485:2016)
• Foster a collaborative relationship with Operations to promote a culture of ongoing education on the Quality Management System
• Facilitate and participate in Customer / Internal audits
• Apply problem-solving skills related to quality issues to ensure timely resolution with minimal impact
• Embrace site PPI initiatives and adopt this methodology in day-to-day tasks
• Take charge of plant-wide initiatives for addressing and preventing issues, with a key focus on handling customer returns and identifying root causes.
• Serve as a manufacturing liaison during new product development
• Provide Quality mentorship for product-related investigations, deviations, change controls, validation protocols, validation reports, and SOPs

• Ability to communicate effectively with multiple levels of leadership.
• Strong proficiency in technical writing and experience with various software applications, including Excel
• Possess strong organizational and interpersonal skills to manage and prioritize multiple tasks
• Ability to achieve deadlines in a fast-paced environment
• Capability to work independently and collaboratively
• Apply 21 CFR Part 820 and standard ISO 13485:2016 principles into critica daily decisions.

• High school diploma or equivalent experience required
• Bachelor's degree or equivalent experience preferred; applicable experience will be considered

• Manufacturing environment desired
• 3 years’ experience in Quality systems based in ISO 13485:2016 and 21 CFR 820 preferred

• Strong analytical and problem-solving skills
• Effective communication skills across all organizational levels
• Strong technical writing abilities and familiarity with software applications like MS Office or similar, SAP, Salesforce
• Capable to prioritize in a fast-paced manufacturing organization
• Embody the values of the quality culture
• Mastery in conducting investigations and root cause analysis for complaints, non-conforming products, and CAPAs

This role requires the ability to work standing, walking, and occasionally lifting up to 25 pounds. Adherence to safety protocols is mandatory.

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

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.

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.

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