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.
Knowledge & Experience
Software Skills
Communication Skills
Learning Capabilities
Planning and Structure
Responsibilities
Testing newly made products
Reviewing production processes
Creating and improving quality control points
Reviewing and analysing results
Must Have
Bachelor Degree or Higher 2+ years of QC experience.
Passion for quality
Perfect written English
Rigorous and precise Knowledge of mechatronics product
Nice to have
Familiar with MRP/ERP software Good knowledge of ISO 13485 and MDR
What's great about the job
- Great team of smart people, in a friendly and open culture
- No dumb managers, no stupid tools to use, no rigid working hours
- No waste of time in enterprise processes, real responsibilities, and autonomy
- Expand your knowledge of various business industries
- Real responsibilities and challenges in a fast-evolving company
Our Product
Discover our products.
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What We Offer
Each employee has a chance to see the impact of his work. You can make a real contribution to the success of the company.
Perks
A full-time position
Attractive salary package.
Trainings
Training can be obtained whenever is needed.
Bonus Scheme
Performance-based bonus / stock options.
Activity
Company outing, weekly drinks, etc. 现在申请!