Engineer I, QA

Work Schedule

First Shift (Days)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

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

Located in Marietta, OH, at 401 Millcreek Road.

Join the Laboratory Products Division, aiding life sciences research and global quality of life.

Discover Impactful Work:

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.

A day in the Life:

• Knowledge of Regulatory and Quality system requirements (ISO 13485:2016, 21 CFR Part 820)
• Partnership with other site areas to drive a culture of continuous education of the Quality Management System
• 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
• Participate in plant-wide efforts in corrective and preventive actions, focusing on customer returns and root cause solutions.
• Provide Quality support for product-related investigations, deviations, change controls, validation protocols, validation reports, and SOPs

Keys to Success:

Ability to communicate effectively with multiple levels of leadership.

Proficiency in technical writing and experience with various software applications, including Excel

Possess organizational to manage and prioritize multiple tasks

Ability to achieve deadlines in a fast-paced environment

Capability to work independently and collaboratively

Education

Bachelor's degree or equivalent experience preferred; applicable experience will be considered

Experience

Three years’ experience in Quality systems based in ISO 13485:2016 and 21 CFR 820 preferred

Three years’ experience in a manufacturing environment required

Knowledge and experience working in the manufacturing of medical devices preferred

Knowledge, Skills, Abilities

Strong analytical and problem-solving skills

Effective interpersonal 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.

Model the principles of the quality culture.

Experienced in investigations and root cause analysis, non-conforming product and CAPAs.

Physical Requirements / Work Environment

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

Benefits

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.

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.