Senior QA Manager

Skill Requirements

• Education: Bachelor's degree in a scientific, engineering, or related technical discipline required. Master's degree or advanced certifications preferred.
• Professional Experience: 7+ years of progressive QA experience within the IVD, medical device, or regulated life sciences industry. Minimum of 3 years in a QA leadership or management role. Hands-on experience in manufacturing and product quality oversight in a regulated environment.
• Regulatory Expertise: Working knowledge of FDA 21 CFR Part 820, ISO 13485, and other applicable international quality standards. Experience supporting regulatory audits, product inspections, and submissions (experience leading them preferred).
• Leadership & Collaboration: Demonstrated ability to supervise and mentor QA staff, manage priorities, and effectively collaborate in a cross-functional environment. Strong interpersonal and communication skills.
• Technical & Analytical Skills: Proficient in problem-solving methodologies, root cause analysis, and quality improvement tools. Experience with QMS software and documentation systems is a plus.

Qualifications

• ASQ certifications (such as CQE, CQA, or CMQ/OE) preferred.
• Strong organizational and time management skills with the ability to manage multiple projects and deadlines. Ability to promote and sustain a culture of quality awareness, compliance, and continuous improvement.

Responsibilities

• Manage and supervise the QA team's daily activities, ensuring timely and effective execution of quality processes.
• Support the implementation and maintenance of the company's QMS, ensuring ongoing compliance with FDA 21 CFR Part 820, ISO 13485, and other relevant standards.
• Collaborate with R&D, Manufacturing, Regulatory Affairs, and Operations teams to integrate quality requirements into product development, manufacturing, and support processes.
• Lead and support internal and external audits, supplier audits, and management reviews, including preparation of required documentation and follow-up actions.
• Oversee the management of non-conformances (NCRs), CAPAs, complaints, and deviations, ensuring timely investigations, root cause analysis, and effective corrective and preventive actions.
• Assist in the preparation for regulatory inspections and third-party audits, serving as a key member of the audit response team.
• Monitor and interpret relevant regulatory changes and industry trends, advising management on necessary updates to quality systems and processes.
• Develop and track quality metrics (KPIs) to monitor the effectiveness of the QA program and identify opportunities for improvement.
• Provide training and mentorship to QA staff, fostering a culture of continuous improvement and compliance.
• Support risk management activities, including risk assessments and mitigation planning.