Quality Lead (Ampoules)
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Job Location:
Santiago de Querétaro - Mexico
Monthly Salary:
Not Disclosed
Posted on:
3 hours ago
Vacancies:
1 Vacancy
Department:
Job Summary
Ensuring the effective implementation and continuous improvement of the Integrated Management System in compliance with applicable regulations and customer requirements. Direct support to manufacturing areas by managing quality control resources and ensuring process reliability and product quality.
Key leadership role in driving quality performance supporting audits managing KPIs and strengthening GMP/GDP compliance. The manager leads quality teams in inspection and process control ensuring alignment with business objectives and regulatory standards in a highly regulated manufacturing environment.
Key Responsibilities:
Ensure product compliance with customer regulatory and internal quality requirements.
Lead and strengthen the Integrated Management System and quality culture.
Manage Quality Control resources inspection systems and analytical methods.
Monitor KPIs and implement corrective actions for non-conforming results.
Support internal customer and regulatory audits and follow up on action plans.
Ensure qualification and continuous training of quality inspection personnel.
Lead continuous improvement initiatives focused on quality cost and efficiency.
Ensure compliance with GMP GDP and safety policies across assigned areas.
Qualifications :
Bachelors degree completed; specialization in Quality Engineering or related field preferred.
3 6 years of experience in quality processes within manufacturing environments.
Strong knowledge of Quality Management Systems and regulatory standards.
Experience with ISO standards (ISO 9001 ISO 13485 ISO 15378 ISO 14001 ISO 45001).
Proficiency in Lean Manufacturing Core Tools (FMEA Control Plans) and Six Sigma.
Experience with quality problem-solving tools (DMAIC 8D 5 Why Ishikawa).
Knowledge of AQL ANSI tables SAP and Minitab.
Advanced English proficiency (business and technical communication).
Remote Work :
No
Employment Type :
Full-time
Key Skills
- Administrative Skills
- Facilities Management
- Biotechnology
- Creative Production
- Design And Estimation
- Architecture
About Company
Gerresheimer Querétaro S.A. in Mexico produces primary glass packaging for pharmaceutical use. Type I glass is produced in clear and amber glass. The broad product range includes ampoules, serum vials, screw thread vials, ready-to-fill syringes and cartridges.
