Job Summary:
We are seeking a highly skilled and experienced Engineer to join our medical device assembly team. The Production Coordinator will be responsible for ensuring that we are operating at maximum efficiency and that our medical devices are manufactured to the highest quality standards.
Key Responsibilities:
- Production Planning and Scheduling
- Production Team Training
- Production Quality Assurance
- Conduct quality checks and inspections to verify that products meet quality standards
- 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
- Ensure compliance with regulatory requirements and company policies
- Facility and Environment Management (cleanliness)
Qualifications and Skills:
- Bachelor's degree in mechanical engineering
- Minimum of 2-3 years of experience in quality engineering or quality control in a 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 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.
Responsibilities
- Production Planning and Scheduling
- Production Team Training
- Production Quality Assurance
- Facility and Environment Management
Must Have
- BSc or Higher in Mechanical Engineering
- 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
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.
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