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:

1. Conduct quality checks and inspections to verify that products meet quality standards
2. Conduct quality audits and assessments to identify areas for improvement in the production process
3. Develop, implement and maintain quality systems and procedures for medical device assembly
4. Provide guidance and support to production staff to ensure compliance with quality standards
5. Develop and implement quality control plans and procedures for incoming materials, in-process materials, and finished products
6. Analyze quality data and metrics to identify trends and areas for improvement
7. Participate in root cause analysis investigations of quality issues and develop corrective actions to prevent reoccurrence
8. Work with cross-functional teams to develop and implement process improvements
9. Develop and deliver training on quality-related topics
10. Ensure compliance with regulatory requirements and company policies

Qualifications and Skills:

1. Bachelor's degree in engineering
2. Minimum of 2-3 years of experience in quality engineering or quality control in a medical device manufacturing environment
3. Strong knowledge of quality systems and regulations in the medical device industry (FDA, ISO, etc.)
4. Experience with process validation, including IQ/OQ/PQ
5. Strong analytical and problem-solving skills
6. Excellent written and verbal communication skills
7. Ability to work in a team environment and lead cross-functional teams
8. Strong project management skills
9. 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.