Quality Assurance Manager - Solothurn, Schweiz - Ypsomed

Ypsomed

Geprüftes Unternehmen

Solothurn, Schweiz

vor 4 Wochen

Geschrieben von:

Lena Schneider

beBee Recruiter

Beschreibung

In the Quality Management, Regulatory & Medical Affairs area in the Quality Assurance department, we are looking for a customer-oriented and quality-conscious personality in the Production Management Team at the Solothurn site as a

Quality Assurance Manager | %**:

Ref. No. 6219

Location:
Solothurn | HybridHelp us bring to market stateoftheart medical technology solutions by optimizing processes and ensuring quality through your structured approach.

Your main tasks:

Ensure a common standard within Ypsomed with regard to quality and regulatory requirements.
Reviews/approves technical documentation constituents
Provides necessary guidance and support to meet design control requirements
Ensures outstanding inspection readiness for systems in the portfolio

Your profile:

A minimum of a Bachelor's or equivalent degree is required. Focused degree in Computer Science, Information Systems, Business Administration or other related field is preferred
ITIL, Agile, and/or Scrum Master certifications are a plus
At least 4 years of dynamic experience in the pharmaceutical/medical device/biotech or other regulated industry is required
Knowledge of Software as Medical Device (SaMD) is desired, including ISO 13485, IEC 62304, IEC 82304, ISO 1497
Experience in authoring or reviewing validation protocols, Nonconformities, Change Requests, SOPs, Validation Plans and Reports is mandatory