Quality Assurance Manager
Key information
- Publication date:15 November 2024
- Workload:100%
- Contract type:Unlimited employment, Temporary
- Language:German (Fluent), English (Fluent)
- Place of work:Rotkreuz
On behalf of our client, a leading international Life Sciences company, Swisslinx is looking for a Quality Assurance Manager. In this role, you will champion quality by streamlining processes, ensuring regulatory compliance, developing team expertise, and driving impactful quality initiatives across product transfers and audits within global operations.
Contract type - 18 months (extension possible)
Start Date - 1st March 2025
Location - Rotkreuz, Canton Zug
Workload - 100%
Work type - hybrid (2 days remote work per week)
Your mission:
* Review and approve content from daily operations in various areas (Change Control, Nonconformities, project, product, and process documents, and other production-related requirements and proof documents).
* Support and improve local and global processes to meet regulatory requirements or best practices.
* Act as a coach within the team, actively helping to develop individual skills/expertise to meet future business requirements.
* Take an active role in preparing, conducting, and following up on internal and external audits.
* Be responsible for quality-related aspects in design or technical product transfer projects to ensure product quality and compliance.
* Lead and/or support global projects/initiatives in Quality Management or Operations and engage as a process advisor within our QMS.
Your background:
* A completed technical or scientific degree or extensive professional experience in a technical field (or similar).
* At least 5 years of experience in Quality Management of medical devices/IVDs and their regulatory requirements (particularly ISO 13485) (MANDATORY).
* Ability to make decisions even outside one's comfort zone or area of responsibility, develop solutions, and implement them independently (MANDATORY).
* Strong and persuasive communication skills in German and English, with the ability to use these skills in a complex environment (MANDATORY).
* Project management experience (MANDATORY).
* Familiarity with new, agile working methods and willingness to question conventional thinking.
* Audit experience and excellent understanding of QMS (MANDATORY).
* Experience in product releases, deviation management, change management, and projects in Product Care.
* Contributes significantly to team cohesion and development with interpersonal skills.
* Pre/Post Market Quality experience.
* Experience in defining, capturing, and analyzing statistical data to improve product quality and processes.
* Experience in process risk analyses (including pFMEAs) and comprehensive evaluation of measures for product and process changes.
What's on offer
* An initially 18 month contract, with possible extension.
* A chance to develop your career at an internationally renowned Life Sciences company.
* A competitive salary.
* A flexible hybrid working policy.
If this sounds like you, don't hesitate to apply here or reach out directly to Hugo Palejowski, Recruiter: Write an email.
Contract type - 18 months (extension possible)
Start Date - 1st March 2025
Location - Rotkreuz, Canton Zug
Workload - 100%
Work type - hybrid (2 days remote work per week)
Your mission:
* Review and approve content from daily operations in various areas (Change Control, Nonconformities, project, product, and process documents, and other production-related requirements and proof documents).
* Support and improve local and global processes to meet regulatory requirements or best practices.
* Act as a coach within the team, actively helping to develop individual skills/expertise to meet future business requirements.
* Take an active role in preparing, conducting, and following up on internal and external audits.
* Be responsible for quality-related aspects in design or technical product transfer projects to ensure product quality and compliance.
* Lead and/or support global projects/initiatives in Quality Management or Operations and engage as a process advisor within our QMS.
Your background:
* A completed technical or scientific degree or extensive professional experience in a technical field (or similar).
* At least 5 years of experience in Quality Management of medical devices/IVDs and their regulatory requirements (particularly ISO 13485) (MANDATORY).
* Ability to make decisions even outside one's comfort zone or area of responsibility, develop solutions, and implement them independently (MANDATORY).
* Strong and persuasive communication skills in German and English, with the ability to use these skills in a complex environment (MANDATORY).
* Project management experience (MANDATORY).
* Familiarity with new, agile working methods and willingness to question conventional thinking.
* Audit experience and excellent understanding of QMS (MANDATORY).
* Experience in product releases, deviation management, change management, and projects in Product Care.
* Contributes significantly to team cohesion and development with interpersonal skills.
* Pre/Post Market Quality experience.
* Experience in defining, capturing, and analyzing statistical data to improve product quality and processes.
* Experience in process risk analyses (including pFMEAs) and comprehensive evaluation of measures for product and process changes.
What's on offer
* An initially 18 month contract, with possible extension.
* A chance to develop your career at an internationally renowned Life Sciences company.
* A competitive salary.
* A flexible hybrid working policy.
If this sounds like you, don't hesitate to apply here or reach out directly to Hugo Palejowski, Recruiter: Write an email.
By applying for this position, I consent to the Swisslinx Group of companies:
- storing my personal information (including name, contact details, Identification and CV information etc.) on their internal or external servers for the purpose of informing me of potential employment opportunities
- using my personal information or
- supplying it to third parties upon express consent for the purpose of informing me of potential job opportunities
- transferring where applicable my personal information to a country outside the EEA/EFTA
I also hereby agree to the Swisslinx privacy policy (http://www.swisslinx.com/en/legal/privacy-policy) and Terms of Use (http://www.swisslinx.com/en/legal/disclaimer)
