Quality Engineer

Qabird; Pijnacker; On-site; EUR 50,000 - 70,000; Full time

Job summary

Qabird in Pijnacker is seeking a Quality Engineer to join their medical device assembly team. The role involves ensuring that products meet quality standards and that production adheres to regulatory requirements. Ideal candidates should possess a Bachelor's degree in engineering and have 2-3 years of experience in a similar field.

Responsibilities include conducting inspections, developing quality systems, and collaborating with teams to improve processes. The position offers competitive salary and benefits, as well as opportunities for career growth.

Qualifications

• Bachelor's degree in engineering required.
• 2-3 years experience in medical device quality engineering.
• Strong knowledge of FDA and ISO regulations.

Responsibilities

• Conduct quality checks and inspections to ensure compliance.
• Develop and implement quality systems for production.
• Analyze quality data to identify trends and improve processes.

Skills

Quality engineering

Quality control

Quality systems knowledge

Analytical skills

Problem-solving skills

Communication skills

Project management

Teamwork

Education

Bachelor's degree in engineering

Job description

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 improvementsDevelop and deliver training on quality-related topics
9. 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.