Quality Assurance Engineer (Tlaxcala, Tlaxcala, MX)
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Quality Assurance Engineer
Serves as the Qualified Person (QP) as required by governing regulations, ensuring the quality and legitimacy of medicinal products. Responsible for maintaining all necessary processes and procedures for QP certification, overseeing batch release, and ensuring compliance with GMP and regulatory requirements for products manufactured in the country. The QP certifies that each production batch meets the required quality standards and documents this certification appropriately.
Job Description
Perform inspections and process documents on products, intermediates, and raw materials to ensure compliance with specified quality standards and regulatory requirements.
Monitor and analyze production and processes to identify deviations, trends, defects, and improvement opportunities; generate reports and track KPI performance.
Maintain and uphold ISO 9001 certification, and support ISO 14001, and ISO 45001 certifications through systematic audits, documentation, and continuous improvement initiatives.
Maintain and support the Integrated Management System focused on the quality pillar improving operational controls, and quality assurance protocols aligned with internal regulations and legal requirements.
Investigate customer complaints, identify root causes, and develop, implement, and monitor corrective action plans (CAPA).
Support Product Supply System (PSS) implementation and continuous improvement initiatives using Lean tools to drive process efficiency, safety, and cost optimization.
Lead quality training programs for all employees, building a consistent quality culture across the organization, including specialized training for QHSE team members.
Support technology development and transfer projects in collaboration with business and production functions.
Reporting & Key Relationships
Internal: Regional and local Partners, Quality Regional & Global Partners, Regional and Global Regulatory Partners.
External: Government Departments, Laboratory Service Providers, Tollers, Auditors.
Required Qualifications
Bachelor's degree in engineering (Biochemical, Chemical, Industrial, Process & Design, or similar).
Minimum 3 years of experience in quality control, quality assurance, or related areas.
Demonstrated leadership with effective facilitation and communication skills.
Broad understanding of legal requirements and quality control regulations, standards, and methodologies.
Proficiency in quality control tools and software.
Strong results orientation with effective prioritization skills.
English: Intermediate level.
Technical & Systems Knowledge
ISO 9001, 14001 and 45001.
Integrated Management System (SIG)
SAP
Good Laboratory Practices (GLP) & Good Manufacturing Practices (GMP)
Official regulations of Mexico
Período de aplicación: 01 al 15 Septiembre Código de referencia: 882878 División: Crop Science Ubicación: Mexico : Tlaxcala : Tlaxcala Área funcional: Calidad Grado de posición: H Tipo de empleo: Permanente Tiempo de trabajo: INDEFINIDO - FULL TIME
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Job details
How this role compares
Computed from every other active Quality role in our database, not just this employer's listings.
We currently track 1075 comparable Quality roles across 129 biopharma companies.
Salary context
197 of 1075 peers report a salary range (USD, annualized)
Peers share this role's job function. This posting doesn't list a seniority level, so peers aren't narrowed by seniority either -- the range below may span more levels than usual.
Where these roles are based
Top locations among the 1075 comparable roles
+ 48 more countries
Seniority mix
475 of 1075 peers have a known seniority level
Therapeutic area mix
2 of 1075 peers have a known therapeutic area; the rest are genuinely unlabeled, not hidden
Similar opportunities
The closest matches from our peer group, ranked by how similar they are, not how well you'd qualify for them -- treat this as market context, not a guaranteed shortlist; a weak match is labeled as one below.
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How we calculate "similar"
No black box, no LLM guesswork: a deterministic score built from four normalized attributes. Here's this role's own peer group at different match levels, so you can see the mechanism, not just the result.
Every comparison starts from the same 100-point budget: 25 for working in the same function, 40 for the same therapeutic area, 20 for the same or adjacent seniority, 15 for the same country. A dimension we can't confirm on both sides contributes nothing, never a guess, never a free pass.
0 points, never a partial guess. A role we know almost nothing about beyond its function bottoms out at 25%; it never inflates to 100% just because there's little to compare against. Seniority uses a defined ladder (Associate → Manager → Associate Director → Senior → Principal → Director → Senior Director → Executive/VP) so "Director" and "Senior Director" count as adjacent, but "Director" and "Executive/VP" do not.