SQA Process Engineering

Supplier Quality Engineer

About the Role

Were looking for people who embody our values arent afraid to challenge innovate experiment and move at a fast pace. Were always looking for ways to improve our products and ourselves. If this is you wed 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.

• Asure 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

• Bachelors degree in engineering or equivalent.

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

• Experience in similar position (SQA)

• Visa Laser

• Demonstrate effective communication presentation and influencing skills fluidly 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 youll feel valued empowered to grow and challenged to achieve business results in a collaborative and open atmosphere. Innovate for GoodExcel Together Be You with Us

Ubicación: Planta Reynosa

Innovate for Good Excel Together Be You with Us

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Reynosa Villa Florida

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