Job Description

DIRECT CANDIDATES ONLY, IF INTERESTED APPLY THROUGH JOB POST. NO DIRECT MESSAGES.

RECRUITERS: DO NOT CONTACT.

Role Description:

The Quality System Manager is responsible for managing and maintaining the quality management system (QMS) to ensure compliance with global medical device regulations and standards, including FDA 21 CFR Part 820, ISO 13485, and other applicable requirements. This role oversees internal audits, CAPA processes, document control, supplier management, and supports regulatory inspections and audits. The ideal candidate has strong leadership, analytical, and communication skills, and a thorough understanding of medical device quality systems.

Essential Duties and Responsibilities:

• Lead and manage the company’s Quality Management System (QMS) in compliance with FDA QSR, ISO 13485, MDSAP, EU MDR, and other applicable regulations.
• Oversee and continuously improve core QMS processes, including CAPA, nonconformance, complaint handling, risk management, internal audits, change control, and document control.
• Maintain quality system documentation, including SOPs, work instructions, and policies, ensuring proper documentation practices and record retention.
• Analyze QMS data and generate metrics to identify trends, monitor key performance indicators, and recommend continuous improvement opportunities.
• Provide training and mentoring on quality system procedures and best practices; evaluate training needs and deliver updated programs.
• Prepare for and lead internal and external audits (e.g., FDA inspections, notified body audits); ensure timely resolution of findings and maintain audit readiness.
• Perform internal audits against relevant standards such as 21 CFR 820, ISO 13485, and ISO 14971.
• Manage CAPA programs, ensuring effective root cause analysis and resolution of product and process quality issues.
• Support supplier management activities
• Support complaint investigations and post-market surveillance activities in alignment with regulatory and internal quality requirements.
• Provide oversight for the development and maintenance of quality programs, systems, and procedures that align with corporate policies and regulatory expectations.
• Participate in Management Reviews and quality system performance reporting for senior leadership.
• Monitor product performance and customer feedback to drive quality improvement initiatives.
• Stay current with evolving regulatory requirements and industry trends to ensure compliance and identify areas for innovation.
• Perform other quality-related duties as assigned.

Education:

• Bachelor’s degree is a must
• Minimum of 10 years of relevant experience with 5+ years of managerial experience, or advanced degree with a minimum of 7 years of relevant experience with 5+ years of managerial experience
• Certified Quality Auditor

Required Experience:

• Leadership experience - leading people, staff, projects at high levels
• Knowledge of domestic and international medical device quality system regulations and standards, such as 21CFR Part 820, ISO 13485: 2016, ISO 14971, MHLW/PMDA (Japan) MDSAP and MDR is a must
• Experience in complaint handling and vigilance reporting is a plus.
• Knowledge of global post-market surveillance regulation (MDD/MDR and other applicable country-specific regulations)
• Experience with ERP systems, electronic document and record management systems
• Excellent computer skills with Microsoft Word, Excel, and etc.
• Excellent communication skills and technical writing skills.
• Ability to pay attention to details and think critically.
• Ability to manage competing priorities in a fast paced environment
• Must be able to handle multiple tasks, prioritize activities, and complete work on time.
• Intellectually curious and eager to learn.
• Professional, responsible, energetic, and accountable.

Knowledge, Skills,and Abilities:

• Attention to detail
• Understanding of GMP and GDP
• Computer literate and experience with PCs, networks, and applications

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