Quality Assurance Manager

Responsible for ensuring compliance with and adherence to ISO 13485 standard and FDA 21 CFR 820. Maintains registration of FDA Class 1 and Class 2 devices. Formulate and implement corrective / preventative actions to resolve customer complaints or non-conformances and perform root cause analysis. Oversee internal quality KPIs and audits. Host external audits (customer, ISO registrar, FDA). Develop and initiate standards and methods for inspection, testing, and/or evaluation. Formulate and maintain quality objectives and coordinate them with procedures and other disciplines. Participate in the planning and design of quality procedures.

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KEY RESPONSIBILITIES:Quality Management Systems:Establish and maintain robust quality management systems (QMS) that align with applicable FDA and ISO requirements and support organizational objectives.Develop and implement quality policies, procedures, and work instructions to ensure adherence to regulatory standards and best practices.Supervise regular internal audits and management reviews to evaluate the effectiveness of the QMS and identify opportunities for improvement.Regulatory Compliance:Stay current with FDA regulations, ISO standards, and other relevant guidelines applicable to the organization's products or services.Develop and implement strategies to ensure compliance with FDA regulations and ISO 13485 (Quality Management for Medical Devices).Coordinate and manage FDA inspections, ISO audits, and other regulatory assessments, ensuring prompt response and resolution of findings.Product Quality Assurance:Monitor and analyze product quality metrics, complaint trends, and non-conformance incidents to implement corrective and preventive actions.Collaborate with product development teams to integrate quality considerations into the design, development, and manufacturing processes.Implement corrective and preventative actions based on nonconformances and/or complaints.Risk Management:Develop and maintain risk management plans and strategies to address potential hazards, failures, or adverse events related to products or processes.Assist with and implement risk assessments, FMEA (Failure Mode and Effects Analysis), and other risk management activities to proactively manage risks throughout the product lifecycle.Identify, assess, and mitigate risks associated with product quality, regulatory compliance, and business operations in accordance with FDA and ISO standards.Cross-Functional Collaboration:Collaborate closely with cross-functional teams, including R&D, manufacturing, regulatory affairs, and supply chain to foster a culture of compliance, accountability, and continuous improvement, and to ensure alignment of quality and regulatory objectives with business goals.Implement and maintain process validation documentsConduct training and development programs to enhance the knowledge, skills, and capabilities of staff members involved in quality and regulatory activities.

REQUIREMENTSEDUCATIONAL BACKGROUND:Bachelor’s degree in chemistry, engineering, general science or quality is required (chemistry, chemical or material engineering preferred) or equivalent experience.Familiarity with LEAN / Six Sigma toolsEXPERIENCE:Five years of experience in a similar position.Experience in the application of quality systems.Effective communication and negotiation skills.Experience implementing improvements and LEAN / Six Sigma methodologies in manufacturing processes.Experience in problem-solving techniques.SKILLS:Strong analytical skills to interpret complex data and make informed decisions.High attention to detail.Ability to identify issues, analyze root causes and propose effective solutions. xzbcwsv Ability to work collaboratively with other departments, such as operations, supply chain and others.LANGUAGE:English (Bilingual Spanish preferred)SOFTWARE:Office (Excel required), ERP Software (NetSuite or Adage / Assistics Preferred), QMS Software (QPulse Preferred)