Quality Assurance Manager - QMS / Regulatory Compliance (Mexico City)

QIAGEN; Ciudad de México; Presencial; MXN 539,000 - 810,000; Jornada completa

Descripción de la vacante

A global biotechnology company in Mexico City seeks a Quality Manager to optimize quality management systems and ensure compliance with regulations. The ideal candidate will have 2–5 years of experience in quality management, hold a relevant Bachelor’s degree, and be a fluent communicator in both Spanish and English. Responsibilities include managing quality metrics, compliance with Mexican authorities, and collaborating with global teams. The role offers a competitive salary and benefits including health insurance and bonuses.

Servicios

Health Insurance

Dental Insurance

Meal Voucher

Groceries Voucher

Bonus / Commission

Life Insurance

Gym-pass

Employee Assistance Program

Formación

• 2–5 years of professional experience in quality management or regulatory compliance.
• Knowledge of ISO 9001 and ISO 13485 Quality Management Systems.
• Fluent in Spanish and English.

Responsabilidades

• Manage and optimize the QMS in line with global standards.
• Ensure compliance with regulatory authorities.
• Establish and monitor Quality KPIs and internal audits.
• Communicate professionally with authorities.

Conocimientos

Quality management

Regulatory compliance

Auditing

Communication

Collaboration

Bilingual (Spanish and English)

Educación

Bachelor’s degree in relevant field

Descripción del empleo

Overview

At QIAGEN, we are driven by a simple but powerful vision : making improvements in life possible.

We’re dedicated to revolutionizing science and healthcare for the better. From our entrepreneurial roots to our current global presence, we've grown into a force for positive change. With thousands of employees across six continents, collaboration is our greatest strength. We’re always striving to identify talented individuals to join our exceptional teams.

We have played a pivotal role in shaping modern science and healthcare, and we're just getting started. If you're someone who thrives on new challenges, and wants to make a tangible difference in people's lives, then QIAGEN is the place for you.

At QIAGEN, every day is an opportunity to make a real-life impact.

Join us, grow with us, and together, let's shape the future of biological discovery.

Your role

Your tasks :

• Manage and optimize the QMS at QIAGEN Mexico in line with global quality standards.
• Ensure compliance with Mexican regulatory authorities (e.g., COFEPRIS) and international standards by keeping all quality policies, processes, and procedures up to date.
• Act as Sanitary Responsible, carrying out all related duties defined under NOM-241-SSA1.
• Communicate with authorities and regulatory bodies, ensuring clear, accurate, and professional interactions.
• Establish and monitor Quality KPIs, metrics, and internal audits to identify improvements, drive accountability, and maintain compliance.
• Oversee training and document control so that all staff understand, follow, and contribute to QIAGEN’s quality culture.
• Collaborate with global Regulatory Affairs teams to anticipate and respond to changes in regulatory requirements.

Your Profile

• You hold a Bachelor’s degree in Pharmaceutical, Chemical, Biological, Medical, Biomedical Sciences, or a related field, and you possess a valid professional license (cédula profesional) as required under NOM-241-SSA1.
• You bring 2–5 years of professional experience in quality management, regulatory compliance, or quality assurance in the medical device, diagnostics, or another highly regulated industry.
• You have working knowledge of ISO 9001 and ISO 13485 Quality Management Systems and are experienced in maintaining compliance and audit readiness.
• You are a qualified Auditor, preferably a Lead Auditor, with proven experience supporting or leading regulatory inspections and formal audits.
• You demonstrate strong communication and collaboration skills, with the ability to work effectively across local teams and global stakeholders.
• You are fluent in Spanish and English, with the ability to engage confidently with authorities, internal teams, and global counterparts.
• You are willingto travel internationally (5–10%).

What we offer

• Health Insurance
• Dental Insurance
• Meal Voucher
• Groceries Voucher
• Bonus / Commission
• Life Insurance
• Gym-pass
• Employee Assistance Program and internal QIAGEN communities

Our people are the heartbeat of everything we do. Passion drives us as we push boundaries to innovate and evolve. We inspire with our leadership and make an impact with our actions. We cultivate a collaborative, supportive environment where each individual and team can flourish. We champion accountability and encourage entrepreneurial thinking.

QIAGEN is committed to creating an inclusive environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, or disability.