Quality Assurance Engineer
As Quality Assurance Engineer, you will be responsible for ensuring the compliance of the entire production according to the current medical device regulations. You will be located in Breckerfeld, Germany.
What is your mission?
- You ensure product and process quality of the entire manufacturing site
- You revise existing quality plans to reduce inspection efforts to essential needs
- You lead product and process risk assessments (Design- & Process FMEA)
- You implement an in-process inspection & operator self-check strategy
- You implement statistical process control (SPC) within a Total Quality Management (TQM) strategy
- You support product development projects with quality requirements
- You are responsible for the maintenance of an easy-to-use and lean QMS documentation incl. change control
- Preparation and execution of internal and external quality audits
Who are you?
- Min. 7 years professional experience
- You have had an education in Mechanical Engineering (or equivalent)
- You have preferably experience in a micromechanical environment
- You have preferably experience with regulated medical device and Good Manufacturing Practice (GMP) experiences
- Good understanding of quality regulations
- Good level Micosoft Office skills (Excel very important)
- Risk management methodologies such as FMEA (Design & Process)
- German: native level; English: good level
What do we offer you?
- A challenging job with potential for growth in an international and diverse company.
- A permanent contract with full time employment.
- Competitive salary package including benefits (meal vouchers, hospitalization and group insurance).
- A great company culture, based on respect and comradeship.
- An opportunity to contribute to a better, healthier world in collaboration with colleagues who are passionate about what they do.
When applying, be sure to upload your CV and motivational letter to your profile!