Job Description
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: • Three (3) or more years of experience in product engineering, manufacturing engineering and/or quality engineering within the Medical Device Industry. • A Bachelor's Degree in engineering • 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. Your responsibilities will include: • Continuous Improvement: Identify and recommend enhancements in product design and manufacturing processes. Provide quality engineering support for risk management, design changes, and CAPA investigations. • Quality System Expertise: Author, review, and approve Quality System documentation, including NCMR and Engineering Change Control. • Supplier Quality Improvement: Drive supplier quality through engineering analysis and root cause investigations. Collaborate with suppliers to reduce defects and improve yield. • 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. • Product Development Guidance: Offer quality engineering insights for product and process improvements, validating design inputs related to usability, reliability, safety, and manufacturability. • Quality Control Planning: Assure product quality in line with best practices, including material control and process validation, based on risk management outcomes. • Validation and Testing: Author validation and inspection assessments to ensure product release readiness. Select tests and sampling sizes based on criticality. • Regulatory Compliance: Stay updated on relevant quality standards (e.g., Medical Device Directive, US FDA) and adapt quality processes to meet changing requirements. • Computer System Validation: Perform computer system validation and ensure adherence to regulatory standards. • 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). Apply tot his job
Apply tot his job
Apply To this Job