Quality Assurance Manager

Yoh is hiring a Quality Assurance Manager for our medical device manufacturing client in the Los Angeles Metropolitan Area. In this role, you will be responsible for overseeing the daily operations, maintenance, and continuous improvement of the company's Quality Management System (QMS). The Quality Assurance Manager will ensure compliance with ISO 13485, FDA Quality Management System Regulation (QMSR), EU MDR, MDSAP, and applicable regulatory requirements while leading quality initiatives, supplier quality programs, audits, CAPA investigations, and continuous improvement efforts. The ideal candidate will have strong hands-on medical device quality experience, excellent leadership skills, and the ability to collaborate across Regulatory Affairs, Engineering, Operations, Supply Chain, and executive leadership. Industry: Medical Device / Healthcare Products | Location: Los Angeles Metropolitan Area - Onsite | Compensation: $129,000-$145,000 annually (based upon experience) | Type: Direct Hire / Full-Time | Benefits: Medical, Dental, Vision, 401(k), Vacation Job Functions Manage, maintain, and continuously improve the company's Quality Management System (QMS) in accordance with ISO 13485, FDA QMSR, EU MDR, MDSAP, and other applicable regulatory requirements. Oversee document control, change control, training records, nonconformances, deviations, and other core Quality System processes. Develop, review, and maintain SOPs, work instructions, quality procedures, and controlled documentation to ensure regulatory compliance. Lead internal, supplier, customer, Notified Body, MDSAP, and regulatory audits while maintaining continuous inspection readiness. Develop and execute risk-based internal audit schedules and coordinate audit preparation, execution, responses, and corrective actions. Serve as a key Quality representative during external audits and regulatory inspections, including FDA and Notified Body inspections. Lead the Corrective and Preventive Action (CAPA) program, including investigations, root cause analysis, corrective action implementation, and effectiveness verification. Monitor CAPA, nonconformance, and audit trends to identify systemic quality issues and implement sustainable improvements. Partner with Regulatory Affairs to support EU MDR compliance, technical documentation, post-market surveillance, risk management, and regulatory change assessments. Manage supplier quality activities, including supplier qualification, audits, monitoring, quality agreements, corrective actions, and performance evaluations. Evaluate supplier changes and quality events to determine potential impacts on product quality and regulatory compliance. Collaborate with Operations and Supply Chain to ensure appropriate controls are maintained for incoming products, materials, and components. Oversee or support receiving inspections, product testing, sampling, and material disposition activities. Support manufacturing, packaging, sterilization, and inspection process validation and qualification activities. Oversee product complaint handling and quality investigations, ensuring appropriate documentation, escalation, and resolution. Partner with Regulatory Affairs to support regulatory reporting and post-market surveillance requirements. Develop, monitor, and report Quality KPIs, including CAPA performance, complaints, supplier quality, audit findings, nonconformances, and training compliance. Analyze Quality System performance data and identify opportunities for corrective action and continuous improvement. Prepare Quality Management Review reports and presentations for executive leadership. Lead, mentor, and develop Quality team members while establishing performance expectations and departmental priorities. Provide training and guidance on QMS requirements, Good Manufacturing Practices (GMP), documentation practices, and quality procedures. Support the implementation and optimization of electronic Quality Management Systems (eQMS). Promote a culture of quality, regulatory compliance, accountability, and continuous improvement across the organization. Education and/or Experience Bachelor's degree in Engineering, Life Sciences, Quality, Biomedical Sciences, or a related technical discipline required. Minimum of five (5) to seven (7) years of progressive Quality Assurance experience within the medical device, pharmaceutical, biotechnology, or another highly regulated industry. Previous experience working within a medical device Quality Management System required. Strong working knowledge of ISO 13485 and FDA medical device quality system requirements, including FDA QMSR. Demonstrated experience with CAPA, nonconformance management, root cause investigations, document control, change control, complaint handling, and internal auditing. Experience participating in and/or leading FDA, Notified Body, MDSAP, customer, supplier, and certification audits. Demonstrated ability to manage audit findings, regulatory observations, and corrective actions through successful closure. Strong understanding of risk-based decision-making and quality risk management principles. Experience developing and analyzing quality metrics and presenting Quality System performance to management. Strong technical writing skills with experience developing SOPs, work instructions, investigation reports, CAPAs, audit responses, and controlled documentation. Demonstrated leadership experience with the ability to train, mentor, and develop Quality team members. Excellent analytical, organizational, problem-solving, and project management skills. Strong written and verbal communication skills with the ability to collaborate across multiple departments and organizational levels. Ability to independently identify Quality System gaps, develop corrective solutions, and drive improvements through implementation. Ability to manage multiple priorities in a fast-paced, highly regulated environment. Preferred Qualifications Hands-on experience with EU MDR 2017/745, including Quality System requirements and Notified Body audits. Experience supporting MDSAP audits and regulatory inspections. Experience with disposable or sterile medical devices, including syringes, needles, drug-delivery devices, blood collection products, or similar single‑use medical products. Experience managing supplier quality programs, global suppliers, and contract manufacturers. Knowledge of ISO 14971 risk management, post-market surveillance, validation, sterilization, packaging, and medical device manufacturing controls. Experience implementing or managing electronic Quality Management Systems (eQMS). Familiarity with international regulatory requirements and global supply chain quality management. Professional certifications such as ASQ Certified Quality Auditor (CQA), Certified Quality Engineer (CQE), Certified Manager of Quality/Organizational Excellence (CMQ/OE), or Regulatory Affairs Certification (RAC) are highly desirable. Physical Job Requirements Full‑time, onsite work environment within a medical device manufacturing and distribution organization. Position involves both office-based Quality Management activities and hands-on support of manufacturing, warehouse, and quality operations. Regular use of computers and standard office equipment for documentation, data analysis, reporting, and communication. May require standing, walking, or moving throughout manufacturing and warehouse areas during audits, inspections, and Quality System assessments. Must be able to review detailed technical documentation, quality records, inspection reports, and regulatory information. Must follow applicable safety procedures and facility requirements when working in manufacturing or controlled environments. Estimated Min Rate : $129,000.00 Estimated Max Rate : $145,000.00 Benefits Medical, Prescription, Dental & Vision Benefits (for employees working 20+ hours per week) Health Savings Account (HSA) (for employees working 20+ hours per week) Life & Disability Insurance (for employees working 20+ hours per week) MetLife Voluntary Benefits Employee Assistance Program (EAP) 401K Retirement Savings Plan Direct Deposit & weekly epayroll Referral Bonus Programs Certification and training opportunities Note: Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply. Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Visit to contact us if you are an individual with a disability and require accommodation in the application process. For California applicants, qualified applicants 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. All of the material job duties described in this posting are job duties for which a criminal history may have a direct, adverse, and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. 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