Quality Assurance Manager in Solothurn
Quality Assurance Manager - Solothurn
Alex Tosney is recruiting for a QA Manager to join a medical device company at their site based in Solothurn on a permanent basis. This is a fantastic opportunity to join a growing company developing their next generation of products.
The Role: The primary purpose of this position is to manage the QA function and over see quality management systems on a GMP facility.
Further responsibilities will include:
- Participating, monitoring and supporting production and other development projects to comply with all relevant laws, regulations and specifications such as cGMP, ISO 13485, CFR Part 820 and FDA Guidelines.
- Supporting and implementing the daily tasks of Quality Assurance; in particular product releases, change management, quality documentation and processing of deviation notifications.
- Reviewing and approving the processes and documents involved in development and industrialization projects (e.g., design verification/qualification and validation documents).
- Collaboration in internal, customer, government and supplier audits.
- Independent work in multidisciplinary teams.
- Subproject management in assigned projects.
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- Completed technical education (HF, FH or equivalent).
- Experience in project management.
- Proven experience in validation and qualification of production facilities including computer software validation.
- Further education in the field of quality management.
- In-depth knowledge of quality assurance/cGMP.
- Well-versed handling of SAP and Quality Tools (eg FMEA, SPC etc.).
- Fluency in English and German.
For more information or to apply for this position, please contact Alex Tosney on 0041 (0) 782 508 443 or email atosney@ckqls.ch. Please quote reference 45956 in all correspondence.
