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

February 23, 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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