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Engineer II, QA - Miami, FL

May 29, 2026

Work ScheduleStandard (Mon-Fri)Environmental ConditionsAdherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)Job DescriptionAs 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. DESCRIPTION: Join Thermo Fisher Scientific's Quality Assurance team and contribute to our mission to make the world healthier, cleaner and safer. As a Quality Engineer II, you will ensure compliance with quality standards and regulatory requirements across our manufacturing operations. You'll collaborate with cross-functional teams to drive continuous improvement initiatives, lead investigations, and implement corrective actions to maintain our high standards of product quality. This role offers exposure to innovative technologies and the opportunity to directly impact patient care through quality oversight of critical products.Performs statistical analysis and works with manufacturing to investigate, conduct root cause analysis, recommend corrective actions for processes and products and to contribute to and track data to support site level performance to KPIs (e.g. yield improvements, CAPA, complaint and scrap reduction). Those activities include the planning, development and support of processes, procedures and test plans in order to ensure that products manufactured meet internal, customer and regulatory requirements REQUIREMENTS: • Advanced Degree with no prior experience, or Bachelor's Degree plus 2 years of quality assurance experience in GMP/ISO regulated environments, preferably in medical devices, pharmaceuticals or biotechnology • Preferred Fields of Study: Life Sciences, Engineering, Chemistry or related scientific/technical field • ISO 13485/FDA Lead Auditor certification beneficial • ASQ certification (CQE, CQA) advantageous • Strong knowledge of quality systems, cGMP regulations, and standards including ISO 9001:2015, 21 CFR Part 820, 21 CFR Part 211 • Expertise in quality tools and methodologies including risk management, root cause analysis, CAPA, and change control • Demonstrated experience leading investigations, analyzing quality data, and implementing effective corrective actions • Excellent documentation and technical writing skills for developing SOPs, protocols and reports • Strong proficiency in quality management software (TrackWise, SAP QM, etc.) and Microsoft Office suite • Experience conducting internal audits and supporting external regulatory inspections • Demonstrated ability to build consensus and collaborate across functions • Strong verbal and written communication skills • Ability to work independently while contributing effectively in team environments • Strong attention to detail with analytical and problem-solving capabilities • Experience with statistical analysis tools and quality metrics reporting • Project management skills and ability to prioritize effectively • Ability to work in clean room environments when required • Designee for QE Manager as required including attending meetings, participating in customer audits, represent QE team at technical visits and on customer calls. • Strategically planning across the network supporting AQP establishment/strengthening the QE teams as one global network teams.• Support the site change control system including process risk assessment in the form of FMEA tools. • Works directly with customers on complex critical quality issues/complaints. Leads issue/complaint resolution.

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Common Interview Questions And Answers

1. HOW DO YOU PLAN YOUR DAY?

This is what this question poses: When do you focus and start working seriously? What are the hours you work optimally? Are you a night owl? A morning bird? Remote teams can be made up of people working on different shifts and around the world, so you won't necessarily be stuck in the 9-5 schedule if it's not for you...

2. HOW DO YOU USE THE DIFFERENT COMMUNICATION TOOLS IN DIFFERENT SITUATIONS?

When you're working on a remote team, there's no way to chat in the hallway between meetings or catch up on the latest project during an office carpool. Therefore, virtual communication will be absolutely essential to get your work done...

3. WHAT IS "WORKING REMOTE" REALLY FOR YOU?

Many people want to work remotely because of the flexibility it allows. You can work anywhere and at any time of the day...

4. WHAT DO YOU NEED IN YOUR PHYSICAL WORKSPACE TO SUCCEED IN YOUR WORK?

With this question, companies are looking to see what equipment they may need to provide you with and to verify how aware you are of what remote working could mean for you physically and logistically...

5. HOW DO YOU PROCESS INFORMATION?

Several years ago, I was working in a team to plan a big event. My supervisor made us all work as a team before the big day. One of our activities has been to find out how each of us processes information...

6. HOW DO YOU MANAGE THE CALENDAR AND THE PROGRAM? WHICH APPLICATIONS / SYSTEM DO YOU USE?

Or you may receive even more specific questions, such as: What's on your calendar? Do you plan blocks of time to do certain types of work? Do you have an open calendar that everyone can see?...

7. HOW DO YOU ORGANIZE FILES, LINKS, AND TABS ON YOUR COMPUTER?

Just like your schedule, how you track files and other information is very important. After all, everything is digital!...

8. HOW TO PRIORITIZE WORK?

The day I watched Marie Forleo's film separating the important from the urgent, my life changed. Not all remote jobs start fast, but most of them are...

9. HOW DO YOU PREPARE FOR A MEETING AND PREPARE A MEETING? WHAT DO YOU SEE HAPPENING DURING THE MEETING?

Just as communication is essential when working remotely, so is organization. Because you won't have those opportunities in the elevator or a casual conversation in the lunchroom, you should take advantage of the little time you have in a video or phone conference...

10. HOW DO YOU USE TECHNOLOGY ON A DAILY BASIS, IN YOUR WORK AND FOR YOUR PLEASURE?

This is a great question because it shows your comfort level with technology, which is very important for a remote worker because you will be working with technology over time...