Quality Assurance Engineer
Job Description
Join a leading player in the plastics industry, where your contributions will shape the future of medical plastic devices. This role offers a unique opportunity to be at the forefront of quality assurance, working closely with both customers and suppliers to address quality issues in series production. You will be responsible for managing complaints and corrective actions, actively participating in risk management processes, and supporting change management initiatives. Your expertise will be crucial in planning, conducting, and following up on audits, ensuring that production processes meet stringent quality standards. Additionally, you will play a key role in training employees on quality-related topics and regulatory requirements, fostering a culture of excellence within the organization.
Key Responsibilities
As a Quality Assurance Engineer, you will be entrusted with several key responsibilities that are critical to maintaining the highest quality standards in our products.
- Act as a point of contact for customers and suppliers regarding serial quality issues
- Manage complaints and corrective action processes effectively
- Contribute to risk management efforts, including PFMEA
- Assist with change management processes to ensure compliance and quality
- Support the planning, execution, and follow-up of internal and customer audits
- Conduct quality inspections and approvals of series processes
- Provide training to employees on quality-related issues and regulatory requirements
Required Technical Skills
Soft Skills
Qualifications
- Completed technical degree or technician qualification with several years of professional experience
- Extensive experience in quality assurance within the healthcare sector
- Knowledge of Good Manufacturing Practices and relevant standards such as ISO 13485, ISO 14971, and 21 CFR 820
- Experience in managing corrective and preventive actions
Language Requirements
Programming Languages:
Statistical methods, Quality management systems
Spoken Languages:
English, German
Benefits & Perks
- ✓ Modern working environment
- ✓ Flexible working hours
- ✓ On-site canteen
- ✓ Diverse training opportunities
- ✓ Benefits from the collective agreement of the plastics processing industry in Bavaria, including a 38-hour workweek, 30 days of vacation, and company pension schemes
Working Conditions
Full Time
Company Culture
We foster an innovative and collaborative work environment that values creativity and excellence. Our team is dedicated to driving progress and exploring new markets, making sure every employee has the chance to contribute their ideas and grow their career.
Salary Range
Project Types: Not Available
Career Growth: Career progression within the quality assurance department, Opportunities for professional development and training, Potential leadership roles in quality management