H667 - Quality Assurance Technician

The Straumann Group (SIX: STMN) is a global leader in tooth replacement and orthodontic solutions that restore smiles and confidence. It unites global and international brands that stand for excellence, innovation and quality in replacement, corrective and digital dentistry, including Anthogyr, Clear Correct, Medentika, Neodent, NUVO, Straumann and other fully/partly owned companies and partners. In collaboration with leading clinics, institutes and universities, the Group researches, develops, manufactures and supplies dental implants, instruments, CADCAM prosthetics, orthodontic aligners, biomaterials and digital solutions for use in tooth correction, replacement and restoration or to prevent tooth loss.
Headquartered in Basel, Switzerland, the Group currently employs more than 11,000 people worldwide. Its products, solutions and services are available in more than 100 countries.

People and culture are the Straumann Group's greatest assets; they are the keys to high performance and sustainable success. We strive for a culture that builds trust and collaboration, fosters diversity, embraces change, promotes agility, learning and innovation, creates opportunities, allows people to make mistakes and encourages them to take both responsibility and ownership. The fundamental driver of our culture is the player-learner mindset, which we seek to inspire and nurture in every employee.

Job Purpose
As a member of the Supply Chain Compliance team, the Quality Technician ensures the conformity and quality of products and services provided by external parties. You work closely with internal and external partners and support functions in a proactive and customer-oriented approach.

Main Tasks and Responsibilities

1. Incoming goods: Quality Certificates inspection (Co C 2.1/2.2 and Co A 3.1/3.2) and product release in SAP of outsourced Straumann products including email communication with receiving sites.
2. Processing and documentation of Supply Chain related non-conformities (NCR), CAPA & SCARs.
3. Root causes analyses using methods such as 5 Whys, Ishikawa, FMEA, etc.
4. Review and follow-up of corrective and preventive actions with suppliers (SCARs).
5. Writing investigation reports.
6. Setup of Quality Assurance Agreements incl. follow-up.
7. Maintenance of business partner information data.
8. Audit execution follow-up and audit documentation acc. to GDP.
9. General Condition sheet management for subsidiaries and distributors.
10. Document control.
11. Review document attributes in the approval workflow.
12. Manage periodic review of QMS documents.
13. Manage permission / add and remove users into specific user group.
14. Maintain standard overview in the sharepoint list.

Requirements needed
Education
- Technician diploma, professional education, or equivalent title. Advanced graduate studies/degrees are a plus.

Experience
- Previous experience in quality management within the medical devices/pharmaceutical industry, in particular NCR & CAPA processing, supplier controls and product release processes (incl. DHR review possibly).
- Knowledge and understanding of applicable medical device regulations (ISO 13485, FDA QSR, MDR etc.).
- Knowledge/experience working with electronic documentation management systems (EDMS), and ERP (SAP mainly).
- Knowledge in statistical methods and good distribution practice is an asset.

Personal Attributes
- Reliability and diligence, also when working under pressure.
- Innovative, resourceful, and proactive disposition, committed to ensuring continuous improvement of capacity and delivering quality service.
- Ability to communicate effectively with both internal and external personnel.
- Adequate computer skills, including ability to work effectively with MS Office, in particular Excel and Word.
- Fluent (written and spoken) English, preferably also German; any additional language an asset.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or disability.
Employment Type: Full Time
Alternative Locations: Spain : Madrid
Travel Percentage: 0 - 10%
Requisition ID: 15610