Sqa Process Engineering

Essity AB; Reynosa; Presencial; MXN 200,000 - 400,000; Jornada completa

Descripción de la vacante

A global health and hygiene company is seeking a Supplier Quality Specialist in Reynosa, Tamaulipas. The role requires managing supplier-related quality issues and ensuring compliance with company procedures and relevant regulations. Candidates should have at least 2 years of experience, preferably in the medical device sector, and strong bilingual skills in English and Spanish. The ideal candidate will excel in root cause analysis and possess a solid grasp of quality standards. Join us to make a positive change in society and the environment.

Formación

• 2 years of experience in industry; quality experience on medical devices preferred.
• Experience in a similar position (SQA).
• Strong understanding of Root Cause Analysis, Corrective Action, Preventive Action, Efficiency Verification.
• Knowledge of Quality System Regulations and ISO regulations preferred.

Responsabilidades

• Provide timely follow-up on supplier-related quality issues.
• Assure completion of Supplier Audits and/or Surveys.
• Participate in supplier selection qualification.
• Coordinate supplier quality initiatives in the plant.
• Provide guidance on documentation for supplier qualification.

Conocimientos

Bilingual communication (English and Spanish)

Supplier quality management

Root Cause Analysis

Statistical quality tools

Microsoft Office skills

Descripción del empleo

We're looking for people who embody our values, aren't afraid to challenge, innovate, experiment, and move at a fast pace. We're always looking for ways to improve our products and ourselves. If this is you, we'd love to talk.

What You Will Do

Provide a timely follow up and communication on all supplier related quality issues (NCs / SCARs) reported in production / incoming areas, following applicable procedures.

Provide proper analysis, follow up and communication all supplier related customer complaints, following applicable procedures.

Assure the completion of Supplier Audits and/or Supplier Surveys/Assessments, following Supplier Annual Monitoring Plan and applicable procedures.

Participate during supplier selection-qualification and approval to provide required quality-related input/output, following applicable procedures.

Provide support and/or actively participate in internal and/or external audits (FDA, ISO, Corporate).

Work with project teams to coordinate or implement supplier quality initiatives in the plant.

Provide guidance on documentation associated with supplier qualification/approval and supplier-driven changes including supplier validations, supplier quality agreements, process controls, audits, and compliance to regulations and company procedures.

Work with suppliers to improve processes and Quality Systems.

Who You Are

2 years of experience in industry; quality experience on medical devices preferred.

Experience in similar position (SQA).

Demonstrate effective communication, presentation and influencing skills, fluid bilingual English and Spanish required.

Strong experience with supplier quality.

Strong understanding of Root Cause Analysis, Corrective Action, Preventive Action, Efficiency Verification.

Strong Microsoft Office skills (Word and Excel).

Strong working knowledge of statistical quality tools and statistical process control (SPC).

Process Validation Activities skills (IQ/OQ/PQ), preferred.

Strong working knowledge of Quality System Regulations, ISO regulations (ISO13485 preferable), Risk Management, GMPs / GDPs.

Preferred Knowledge on Foreign country (Japan, Brazil, Canadian, China, Europe) Medical Device regulations.

What We Can Offer You

Our purpose, Breaking Barriers to Well-Being, provides meaning to everything we do. Join us to improve well-being for people and drive positive change for society and the environment. At Essity, you'll feel valued, empowered to grow, and challenged to achieve business results in a collaborative and open atmosphere. Innovate for Good | Excel Together | Be You with Us