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)