Engineer III, QA

3 weeks ago

Frederick, Maryland, United States Thermo Fisher Scientific Full time

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

When you're part of the team at Thermo Fisher Scientific, you'll do important work, and you'll have the opportunity for continual growth and learning in a culture that empowers your development. With revenues of more than $40 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.

Location/Division Specific Information

The Frederick, MD location is a critical part of Thermo Fisher's organization, providing support for up to 5 Business Groups and multiple Divisions, from distribution, to Life Sciences and Corporate support. We are a leading provider of innovative products and services. Join our diverse team in Frederick as a part of our Clinical Sequencing Division, and be part of crafting the future of the world.

Discover Impactful Work:

In this role, you will aid to ensure the site meets all requirements for an effective CAPA program governed by ISO 13485 and 21CFR820. Provide QA support to enable the site to perform effective investigational work, identify true root cause and generate robust corrective and preventative actions. This is a very hands-on role and works collaboratively with other departments.

A day in the Life:

  • Working with multi-functional departments for investigations, corrections/corrective actions to ensure accurate documentation and closure, provide trending and issues as appropriate.
  • Analyze and trend all types of data (CAPA, problem records, complaints, on market surveillance) to identify deficient areas and initiate quality improvement projects.
  • Participate in third party audits, external customers, and Agency inspections as needed and support internal activities concerning any identified nonconformities.
  • Write, review, and approve CAPAs to ensure timely resolution of quality problems.
  • Promote and implement improvements and compliance with site Quality Management System requirements.
  • Prepare clearly written business communications.
  • Write, review, analyze and revise written relevant Stand Operating Procedures (SOPs) and submit procedural changes as needed to meet site, regulatory requirements.
  • Support the quality department as assigned.

How will you get there?

Education

  • Bachelor's degree in life sciences, engineering, process engineering, chemistry, biotechnology or related sciences required.

Experience

  • Experience working in ISO 13485 and/or GMP environment
  • 2+ years of work experience in Quality Assurance/Systems/Engineer role
  • Strong digital literacy (Office, Project, Teams, Visio, Word, Excel); experience with Agile, Trackwise and E1 a plus.
  • Experience with Quality tools, methodologies and investigations, including root cause analysis.
  • Strong analytical and problem-solving skills with attention to detail. Can find creative solutions that meet regulatory and business requirements.
  • Proven organizational skills and can balance sophisticated and routine work activities with competing priorities.
  • Highly upbeat, positive demeanor, works well under stress

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

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 *. 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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