ROLE DESCRIPTION: Responsible for assessing and implementing quality programs aimed at continuous improvement of operations related to established standards. Responsible for ensuring compliance with and adherence to guidelines based on ISO 9001 & standards, as well as conducting internal audits of the same. Develops and initiates standards and methods for inspection, testing, and/or evaluation. Formulates and maintains quality objectives and coordinates them with procedures and other disciplines. Participates 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.
• Conduct regular internal audits and management reviews to evaluate the effectiveness of the QMS and identify opportunities for improvement.

2. 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 standards, including ISO 9001 (Quality Management System) 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.

3. 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.

4. Risk Management:

• Develop 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.

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

EDUCATIONAL BACKGROUND:

• A bachelor’s degree in engineering is required (chemical or material engineering preferred).
• Six Sigma Master Black Belt (Desirable)

EXPERIENCE:

• Five years of experience in a similar position within the maquiladora industry.
• Experience in the application of quality systems.
• Effective communication and negotiation skills.
• Experience implementing improvements and 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:

• Bilingual Spanish / English

SOFTWARE:

• Office (Excel required), NetSuite (Optional), QPulse (Optional)

Posted On: Tuesday, October 29, 2024