Quality Engineer

Job Summary
We are seeking a highly skilled and experienced Quality Engineer to join our medical device assembly team. The Quality Engineer will be responsible for ensuring that our medical devices are manufactured to the highest quality standards and that our production processes are in compliance with regulatory requirements.

Key Responsibilities

Conduct quality checks and inspections to verify that products meet quality standards

Conduct quality audits and assessments to identify areas for improvement in the production process

Develop, implement and maintain quality systems and procedures for medical device assembly

Provide guidance and support to production staff to ensure compliance with quality standards

Develop and implement quality control plans and procedures for incoming materials, in-process materials, and finished products

Analyze quality data and metrics to identify trends and areas for improvement

Participate in root cause analysis investigations of quality issues and develop corrective actions to prevent reoccurrence

Work with cross-functional teams to develop and implement process improvements

Develop and deliver training on quality-related topics

Ensure compliance with regulatory requirements and company policies

Qualifications and Skills

Bachelor's degree in engineering

Minimum of 2-3 years of experience in quality engineering or quality control in a medical device manufacturing environment

Strong knowledge of quality systems and regulations in the medical device industry (FDA, ISO, etc.)

Experience with process validation, including IQ/OQ/PQ

Strong analytical and problem-solving skills

Excellent written and verbal communication skills

Ability to work in a team environment and lead cross-functional teams

Strong project management skills

Ability to prioritize and manage multiple tasks and projects simultaneously

If you are a highly skilled and experienced Quality Engineer with a strong background in medical device assembly, we encourage you to apply. We offer a competitive salary, comprehensive benefits, and opportunities for career growth and development.

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