Job Description

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.

KEY RESPONSIBILITIES:

1. 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.

1. 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.

1. 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.

1. 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.

1. 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 documents
• Conduct training and development programs to enhance the knowledge, skills, and capabilities of staff members involved in quality and regulatory activities.

REQUIREMENTS

EDUCATIONAL 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 tools
• EXPERIENCE:
• 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.
• 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)