Quality Assurance Manager

Yoh Services LLC; Redondo Beach (CA); On-site; USD 129,000 - 145,000; Full time

Benefits offered by this job

Medical, Dental, Vision

401(k)

Vacation

Job summary

Yoh is seeking a Quality Assurance Manager for a medical device client in the Los Angeles area. The role oversees the QMS, ensuring compliance with ISO 13485, FDA QMSR, EU MDR, and MDSAP while guiding audits, CAPA, and continuous improvement initiatives.

The candidate will collaborate with Regulatory Affairs, Engineering, Operations, and Supply Chain, driving risk-based decisions and ensuring inspection readiness across internal and external audits. Onsite, full-time, with competitive benefits.

Qualifications

• Bachelor's degree in a technical field and 5–7 years in quality assurance within regulated industries.
• Strong knowledge of ISO 13485 and FDA QMSR requirements.
• Experience leading CAPA, nonconformance, and internal audits.

Responsibilities

• Oversee the QMS to ensure ISO 13485, FDA QMSR, EU MDR, and MDSAP compliance.
• Lead audits with regulatory bodies, suppliers, Notified Bodies, and customers.
• Develop and implement CAPA investigations, root cause analyses, and corrective actions.
• Monitor quality metrics and drive continuous improvement across functions.
• Collaborate with Regulatory Affairs, Engineering, Operations, and Supply Chain.

Skills

Quality Assurance

Regulatory Compliance

Audits

CAPA

QMS

Leadership

Cross-Functional Collaboration

Education

Bachelor's degree in Engineering, Life Sciences, Quality, Biomedical Sciences, or related technical discipline

Tools

eQMS

Job description

Yoh is hiring a Quality Assurance Manager for our medical device manufacturing client in the Los Angeles Metropolitan Area.

The Quality Assurance Manager will be responsible for overseeing the daily operations, maintenance, and continuous improvement of the company's Quality Management System (QMS).

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.

#IND-SPG

Estimated Min Rate: $129000.00

Estimated Max Rate: $145000.00

What’s In It for You?

• 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

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 https://www.yoh.com/applicants-with-disabilities to contact us if you are an individual with a disability and require accommodation in the application process.

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