Quality Assurance Specialist

hace 2 meses

Tijuana, Baja California, México Carlisle Medical Technologies A tiempo completo
Job Summary

We are seeking a Quality Engineer to join our team at Carlisle Medical Technologies.

Job Description:

As a Quality Engineer, you will be responsible for ensuring the safety and quality of our products and procedures. This includes:

  • Rigorous inspections and implementation of quality control measures;
  • Identification of areas for improvement;
  • Collaboration with cross-functional teams to address quality issues;
  • Driving continuous improvement;
  • Contributing to building high-quality products that exceed customer expectations.

You will possess a strong background in engineering or quality assurance, attention to detail, and a proactive mindset.

Key Responsibilities:
  • Contribute to all cost-saving and safety initiatives;
  • Generate and maintain process requirements, specifications, validation, and confirming quality documents;
  • Develop and manage Quality Engineering Technicians;
  • Execute test method validations and Engineering Tests;
  • Develop and maintain FMEA's and Control Plans;
  • Perform, maintain, and sustain activities under QMS;
  • CAPA, NMCRs, and Customer complaints root cause investigations;
  • Coordinate and/or contribute in DHRs processes;
  • Generate weekly and monthly reports using quality objectives;
  • Provide support during customer visits;
  • Set detailed guidelines on what needs to be checked and what the quality standards are;
  • Update the Quality Management System (QMS) with incidents, fixes, and improvements;
  • Audit our quality systems based on standards requirements;
  • Monitor the entire production cycle and perform regular tests to identify potential malfunctions as early as possible;
  • Inspect product for defects and identify the root of technical issues and recommend fixes;
  • Prepare reports on malfunctions and corrective actions;
  • Review quality documentation;
  • Set and track quality assurance goals;
  • Coordinate with external quality assurance auditors and technicians to ensure legal compliance;
  • Work with internal teams to increase customer satisfaction by improving the quality of the products.
Requirements:
  • Bachelor's degree in engineering (industrial, chemical, manufacturing, or any other related);
  • Ideal to have previous experience in Medical Devices / Quality System ISO 13485;
  • And/or is preferable required at least 2 years of experience in similar position;
  • Advanced Computer skills (Minitab, Office, Word, Excel, Power Point, and/or Application Programs, Statistical Software, Databases, etc.);
  • Capability to train and develop people;
  • Knowledge of National and International Standards related to quality;
  • Certification Desirable (Green Belt, Certified Lead Auditor, Certified Quality Engineer, or any other related);
  • Knowledge of ISO 14001 Environmental management System.
Estimate Salary Range

$80,000 - $120,000 per year.

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