Creation and tracking of supplier complaints and internal deviation reports
Creation and support in the processing of change control procedures
Creation, review and approval of product-related documents
Participation in ongoing development projects
Carrying out document exchanges at the Buchen site
QA review of documentation for qualification and validation of rooms, equipment and methods for manufacturing and (in-process) testing.
Preparation of quarterly reports for environment monitoring
Assist with customer audits, supplier audits and internal audits.
Ensure compliance with regulatory and normative requirements throughout the life cycle of the product
Overall supervision of series production processes with regard to quality-relevant topics
Administration of the archive at the Buchen site
What you offer
Technical training or alternatively a technical degree with at least 3 years of professional experience in the field of Quality Assurance
Knowledge of DIN EN ISO 13485
Knowledge in GMP
Good handling of common MS Office products
Good knowledge of German and English, both written and spoken
Planned, structured and reliable way of working
Assertive personality
Professional, social and methodical competence
What we offer
working in highly motivated, international teams
Dedicated people who put the needs of patients at the center of their doing
Performance-based salary, attractive benefits and a flexible and modern working environment
Who we are
Haselmeier, a part of medmix, has been established in the healthcare marketplace for over 100 years. With approximately 250 employees, Haselmeier has been pioneering the development of injection pens for subcutaneous application since the 1960s. We continue to drive innovation in self-injection pens from design and manufacturing to packaging and delivery. We have developed solutions in scalable volumes for numerous pharmaceutical partners, always following state-of-the-art engineering practices – and we aim to evolve even further. We design our products with a patient-centric approach. Our injection devices are used in a variety of therapeutic areas, helping patients living with diabetes, supporting fertility treatment and even being an option for low-impact cancer therapy
Join us to impact the world of healthcare
If you are looking for an exciting job in a growing company with pleasant atmosphere and short distances, then apply!
