Quality Operations Lead: FDA/ISO 13485 Compliance & Audits

Mam de la Frontera, S.A. de C.V.; Tecate; On-site; MXN 1,000,000 - 1,500,000; Full time

Job summary

Mam de la Frontera, S.A. de C.V. seeks a Quality Operations Leader to run daily quality activities at the Tecate site. You will oversee inspections, testing, and product release, while managing the QMS, CAPAs, and audits with a focus on regulatory compliance.

You will mentor Quality Engineers and QA staff, report KPIs monthly, and champion risk management and continuous improvement; travel up to 20% internationally may be required, with fluent English essential.

Qualifications

• Bachelor’s degree in engineering, quality, or related scientific field (or equivalent experience).
• Minimum 5-8 years in Quality within a regulated manufacturing environment, or advanced degree with 3 years of relevant experience.
• 3+ years leading Quality Operations in a medical device manufacturing site and Quality projects.
• Strong knowledge of ISO 13485, MDSAP, FDA QMSR (21 CFR Part 820) and Good Documentation Practices.
• Experience maintaining and improving a Quality Management System and regulatory compliance.
• Experience guiding and coaching others and readiness for audits and inspections.
• Willingness to travel internationally up to 20% and fluent English (reading, writing, speaking).

Responsibilities

• Lead daily quality operations at the manufacturing site, including incoming, in-process, and final inspection, testing, and product release.
• Oversee QMS processes such as change control, document management, records retention, training, CAPA, NCMR, complaints, and calibration.
• Supervise and develop Quality Engineers and QA personnel, including performance management and coaching.
• Ensure compliance with FDA QMSR, ISO 13485, MDSAP and Good Documentation Practices through procedures and controls.
• Lead internal and external audits, including ISO/MDSAP audits and regulatory inspections, as site host.
• Maintain and monitor quality metrics and KPIs, presenting monthly results and driving actions through governance.
• Lead investigations for quality trends, implementing CAPA, and drive continuous improvement.
• Support risk management processes and ensure integration into key quality activities.

Skills

English fluency

Leadership

Coaching

Communication

Travel flexibility

Education

Bachelor’s degree in engineering/quality/science

Advanced degree (optional)

Tools

Microsoft Office

ERP/QMS systems

Job description

Mam de la Frontera, S.A. de C.V. seeks a Quality Operations Leader to run daily quality activities at the Tecate site. You will oversee inspections, testing, and product release, while managing the QMS, CAPAs, and audits with a focus on regulatory compliance.

You will mentor Quality Engineers and QA staff, report KPIs monthly, and champion risk management and continuous improvement; travel up to 20% internationally may be required, with fluent English essential.