Quality Engineer (Visa Sponsorship or Relocation Assistance Not Available)

Position Summary

The Quality Engineer will be responsible for ensuring the highest quality standards in a fast-paced work environment. The role focuses on metrology, GD&T, CAPA, validation, and continuous improvement initiatives. Additionally, the position will involve procedure writing, training, customer liaison, and complaint handling to ensure regulatory compliance and customer satisfaction.

Specific Functional Areas

• Create and maintain system procedures & work instructions
• Support the internal auditing program
• Data analysis
• Complaint handling
• CAPA investigations

Metrology Job Specific Competencies

• Perform dimensional inspections using a variety of metrology equipment
• Ensure accuracy and traceability of measurement systems
• Geometric Dimensioning & Tolerancing (GD&T)
• Interpret and apply GD&T principles to product designs and inspection processes
• Corrective And Preventive Action (CAPA)
• Lead the investigation of quality issues, root cause analysis, and implementation of corrective and preventive actions
• Monitor and document CAPA activities to ensure timely closure and compliance with regulatory standards

Validation Support

• Support validation activities for equipment, processes, and software (IQ, OQ, PQ)
• In compliance with regulatory requirements
• Develop validation protocols and reports, ensuring that systems meet defined specifications

Training

• Develop and deliver training on quality standards, procedures, and best practices to the team and operators
• Ensure training compliance for quality-related processes and systems

Continuous Improvement Projects

• Lead and participate in continuous improvement initiatives (Lean, Six Sigma)
• To enhance product quality and process efficiency
• Identify opportunities to improve processes and reduce defects

Regulatory Compliance

• Ensure compliance with relevant regulatory standards, such as ISO 13485, FDA 21 CFR Part 820, and EU MDR
• Maintain accurate and thorough documentation to meet regulatory and customer requirements

Procedure Writing And Documentation

• Develop, review, and update quality system procedures, work instructions, and inspection criteria
• Ensure all documentation is aligned with industry regulations and best practices

Knowledge & Skills

• 3-5 years of experience in the medical device industry, with a focus on quality assurance
• Strong knowledge and understanding of metrology, CAPA, GD&T, experience interpreting engineering drawings and validation processes
• Six Sigma Green/Black Belt or ASQ Quality Engineer certification is a plus
• Proficient in the use of metrology equipment and software
• Knowledge of quality management systems (QMS) and regulatory standards
• Excellent problem-solving and analytical skills
• Superior written and strong communication skills for liaising with customers and cross-functional teams
• Ability to manage multiple projects and meet deadlines

Minimum Educational Qualifications

Must have a Bachelor’s degree in Engineering.