Quality Systems Specialist

JOB REQUIREMENTS: Position Summary The Quality Systems Specialist is responsible for supporting, maintaining, and continuously improving the Quality Management System (QMS). This role ensures compliance with FDA Quality System Regulation (QMSR, 21 CFR Part 820) and ISO 13485:2016 and supports quality activities for Class I medical devices, with future scalability to Class II products. This is a hands-on role requiring active participation in quality system administration, audits, CAPA, supplier quality, complaints, and regulatory compliance activities. Key Responsibilities * Maintain and improve the ISO 13485-compliant Quality Management System. * Manage document control, record retention, and training records. * Support supplier qualification, supplier audits, and Approved Supplier List maintenance. * Maintain Design History Files (DHF), change controls, and quality records. * Support risk management activities in accordance with ISO 14971. * Assist with process validation activities (IQ/OQ/PQ). * Review and investigate nonconformances and support CAPA activities. * Manage complaint handling, product returns, and post-market quality activities. * Participate in internal audits and support FDA and ISO inspections. * Prepare quality metrics, audit summaries, and management review inputs. * Promote quality system compliance and continuous improvement across the organization. Required Qualifications Education * Bachelor's degree in Engineering, Life Sciences, Quality, or related scientific discipline preferred. Experience * 5+ years of quality experience in the medical device industry. * Experience supporting an ISO 13485 Quality Management System. * Experience with CAPA, complaint handling, supplier quality, audits, and document control. * Experience supporting FDA inspections and/or ISO certification audits preferred. * Small-company or startup medical device experience preferred. Knowledge & Skills * Working knowledge of FDA QMSR and ISO 13485:2016. * Familiarity with CAPA, supplier quality, validation, complaints, and risk management. * Strong organizational, documentation, and communication skills. * Ability to work independently in a fast-paced environment. Beacon Hill is an equal opportunity employer and individuals with disabilities and/or protected veterans are encouraged to apply. California residents: Qualified applications with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. If you would like to complete our voluntary self-identification form, please click here or copy and paste the following link into an open window in your browser: https://jobs.beaconhillstaffing.com/eeoc/ Completion of this form is voluntary and will not affect your opportunity for employment, or the terms or conditions of your employment. This form will be used for reporting purposes only and will be kept separate from all other records. Company Profile: Founded by industry leaders to set a new standard in search, career placement and flexible staffing, we deliver coordinated staffing solutions with unparalleled service, a commitment to project completion and success and a passion for innovation, creativity and continuous improvement. Our niche brands offer a complete suite of staffing services to emerging growth companies and the Fortune 500 across market sectors, career specialties/disciplines and industries. Over time, office locations, specialty practice areas and service offerings will be added to address ever changing constituent needs. Learn more about Beacon Hill and our specialty divisions, Beacon Hill Associates, Beacon Hill Financial, Beacon Hill HR, Beacon Hill Legal, Beacon Hill Life Sciences and Beacon Hill To view the full job description please use the link below. https://www.aplitrak.com/?adid=YmJnZW5lcmljLjczMjEzLjg3NzBAYmVh 29uaGlsbGNvbXAuYXBsaXRyYWsuY29t ***** APPLICATION INSTRUCTIONS: Apply Online: https://www.aplitrak.com/?adid=YmJnZW5lcmljLjczMjEzLjg3NzBAYmVhY29uaGlsbGNvbXAuYXBsaXRyYWsuY29t