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Quality Engineer (Medical Device Industry Experience required), Temporary, Remote

February 21, 2026

FlexStaff is seeking a Quality Engineer with experience in Medical Device manufacturing to work with one of our clients, a leading global distributor of healthcare products and services for their manufacturing division in Ontario, California. This is a contract job until June 30, 2026. Schedule: Monday to Friday, 11am- 8:30pm EST. What You'll Do: Develop and implement systems to ensure products and/or services are designed and produced to meet or exceed customer expectations and regulatory requirements, including the US Food and Drug Administration, Health Canada, European MDD/MDR. Minimum requirements: <ul> <li>Three (3) or more years of experience in product engineering, manufacturing engineering and/or quality engineering within the Medical Device Industry. </li> <li>A Bachelor's Degree in engineering</li> <li>Strong working knowledge of medical device regulations including 21CFR820, MDD, MDR and other global regulatory requirements and quality system standards including ISO14971, IEC 60601 and other relevant standards. </li> </ul> Your responsibilities will include: <ul> <li>Continuous Improvement: Identify and recommend enhancements in product design and manufacturing processes. Provide quality engineering support for risk management, design changes, and CAPA investigations.</li> <li>Quality System Expertise: Author, review, and approve Quality System documentation, including NCMR and Engineering Change Control.</li> <li>Supplier Quality Improvement: Drive supplier quality through engineering analysis and root cause investigations. Collaborate with suppliers to reduce defects and improve yield.</li> <li>Trend Analysis: Conduct periodic product and process trend analyses to ensure quality, patient safety, and regulatory compliance. Implement corrective actions and problem-solving methodologies to reduce defects.</li> <li>Product Development Guidance: Offer quality engineering insights for product and process improvements, validating design inputs related to usability, reliability, safety, and manufacturability.</li> <li>Quality Control Planning: Assure product quality in line with best practices, including material control and process validation, based on risk management outcomes.</li> <li>Validation and Testing: Author validation and inspection assessments to ensure product release readiness. Select tests and sampling sizes based on criticality.</li> <li>Regulatory Compliance: Stay updated on relevant quality standards (e.g., Medical Device Directive, US FDA) and adapt quality processes to meet changing requirements.</li> <li>Computer System Validation: Perform computer system validation and ensure adherence to regulatory standards.</li> </ul> *Additional Salary Detail The salary range and/or hourly rate listed is a good faith determination of potential base compensation that may be offered to a successful applicant for this position at the time of this job advertisement and may be modified in the future. When determining a team member’s base salary and/or rate, several factors may be considered as applicable (e.g. location, specialty, service line, years of relevant experience, education, credentials, negotiated contracts, budget, and internal equity).

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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...