Job Title: Quality Manager

Job Description

We are seeking an experienced Quality Manager to lead and maintain our Quality Management System (QMS) in compliance with FDA and other regulatory requirements. This role involves managing audits, overseeing quality processes, and collaborating with cross-functional teams to ensure product excellence.

Responsibilities

• Lead and maintain the company’s QMS in compliance with FDA and other regulatory requirements.
• Manage internal and external audits, including FDA inspections and ISO certification audits.
• Oversee CAPA, nonconformance, and complaint handling processes.
• Collaborate with cross-functional teams (R&D, Manufacturing, Regulatory) to ensure quality is built into every stage of the product lifecycle.
• Develop and monitor quality metrics and KPIs; report findings to leadership.
• Lead training programs on quality standards, procedures, and best practices.
• Manage document control, change control, and risk management processes.
• Supervise quality assurance and quality control staff.
• Other duties and special projects as assigned.

Essential Skills

• Quality engineering
• Quality assurance
• Root cause analysis
• Medical device industry experience
• CAPA
• Quality management
• AS9100
• Quality management system

Additional Skills & Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or related field (Master’s preferred).
• 5+ years of experience in quality management within the medical device industry.
• Strong knowledge of FDA QSR and risk management (ISO standards).
• Experience with CAPA, root cause analysis, and audit readiness.
• Excellent leadership, communication, and problem-solving skills.
• ASQ certifications (e.g., CQE, CQA) are a plus.

Work Environment

This position involves working closely with cross-functional teams and requires strong collaboration skills. The work environment prioritizes compliance with regulatory standards and continuous improvement. Typical office attire is expected.