Engineer II, Quality Assurance
Thermo Fisher Scientific

Job Description

The Marietta Manufacturing site is a part of the Laboratory Products Division. Our laboratory equipment products are used primarily by pharmaceutical companies for drug discovery and development and by biotechnology companies and universities for life science research to advance the prevention and cure of diseases and enhance quality of life. Our offering consists of equipment, accessories, and services for sample preparation, storage and protection, and analysis.

Engineer II, Quality Assurance

Location: US - Marietta, OH - 401 Millcreek Road

Discover Impactful Work:

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.

A day in the life:

• Maintain working knowledge of Regulatory and Quality system requirements (ISO 13485)
• Cultivate a partnership with Operations to drive a culture of continuous education of the Quality Management System
• Facilitate and participate in Customer / Internal audits.
• Utilize 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.
• Drive plant wide corrective and preventive action activities (using 8D, A3, and similar methodologies) with special emphasis on evaluation of returned customer product and leading corrective action teams to determine solutions to permanently eliminate root cause.
• Serve as a manufacturing liaison during new product development.
• Provide Quality guidance to product-related investigations, deviations, change controls, validation protocols, validation reports, and SOPs.

Required Qualifications:

• Bachelor's degree in Engineering is required; Associates Degree will be considered with applicable engineering experience.

Preferred Qualifications:

• 5 years' experience in Quality systems based in ISO 13485:2016 and 21 CFR 820 preferred.
• 5 years' experience in manufacturing environment desired.
• Knowledge and direct experience working in the manufacturing of medical devices strongly desired.

Knowledge, Skills, Abilities:

• Excellent computer skills, display specific expertise in MS Office.
• Communicate effectively with multiple levels of staff throughout the organization.
• Possess strong organizational skills to manage and prioritize multiple tasks.
• Ability to achieve deadlines in a fast-paced environment.
• Strong analytical and problem-solving skills.
• High degree of proficiency in technical writing
• Ability to work independently and in a group setting with little direction.

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.

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