Quality System Engineer (Digital Health Technologies) (m/f/d) — Coopers Group AG
- Location
- Basel-Stadt
- Contract
- contracting
- Posted
- Yesterday
Role overview
For our client from the Pharma Industry, we are looking for a Quality System Engineer with in-depth knowledge and experience with Digital Health technologies, with a focus on regulatory aspects
- For our client from the Pharma Industry, we are looking for a Quality System Engineer with in-depth knowledge and experience with Digital Health technologies, with a focus on regulatory aspects
- Serving as the single point of contact: for technical conversations with third party device manufacturers regarding design controls, risk management, and agreements.
- Act as the Subject Matter Expert (SME) on device requirements and technical nuances; also ensure these elements are appropriately integrated into study protocols and documentation.
- Engineering - Quality Management Basel-Stadt Contracting Full Time ASAP (latest 1st of September) - 12 months Quality Management Systems
Main responsibilities
- Serving as the single point of contact: for technical conversations with third party device manufacturers regarding design controls, risk management, and agreements.
- Act as the Subject Matter Expert (SME) on device requirements and technical nuances; also ensure these elements are appropriately integrated into study protocols and documentation.
- Compile and maintain the "Asset List" (Technical Documentation), perform technical reviews of manufacturer data, and author or review technical content for submission documents.
- Digital & Regulatory Identity: Co-lead the regulatory characterization of DHTs with the Product Management & Design Leaders, which involves providing input into Roche’s internal Device Regulatory Assessment and supporting updates.
- Change Control: Act as the intake point and primary assessor for changes during a study, rigorously evaluating the impact on technical accuracy, documentation, and overall study integrity.
- Work will also help inform third party manufacturers of updates needed in their design control documentation.
- Evaluation: Support manufacturer qualification activities with Quality, Product Managers, Business Strategy & Operations and Procurement teams to evaluate vendor capabilities and identify technical gaps to inform viability of use as a third party manufacturer.
- Remediation: Oversee the manufacturer's delivery and lead any needed remediation efforts (when needed) to address updates to documentation.
- Review Manufacturer Design History Files (DHFs) and product development documentation: from the third party DHT product manufacturers
- Conduct Risk Management and computer systems validation (CSV) for products not classified as medical device, when necessary and per global standard operating procedures (SOPs)
Key requirements
- Engineering - Quality Management Basel-Stadt Contracting Full Time ASAP (latest 1st of September) - 12 months Quality Management Systems
Additional details
- Support upskilling: activities and plans to train team members new to medical device development, design control, regulatory assessment and quality documentation activities.
- Track record of effectively working in a matrix environment with global team members Fluent in English, German is of advantage
Notes and original content
- Responsibilities :
- Must haves :
- Track record of effectively working in a matrix environment with global team members
- Fluent in English, German is of advantage
Questions about this listing
What salary does Coopers Group AG offer for this role?
Coopers Group AG lists CHF 62'000 - 94'000 gross per year for this position in Basel-Stadt. This is the salary published in the original listing (or, when the employer omits a figure, a realistic estimate for the role and sector) — the calculator on this site converts it to your actual net take-home once cross-border tax and social contributions are applied.
Is this a full-time role, and what type of contract does Coopers Group AG offer?
This listing is a full-time position. The contract type shown here comes directly from the employer's original posting; always confirm exact hours, notice period and probation length with Coopers Group AG during the application process, since these details can vary by role even within the same contract category.
Do I need a cross-border work permit for a role in Basel?
EU/EFTA residents living in the border zone of the country adjoining Canton Basel can apply for a G permit; the Swiss employer files it with that canton's migration office after the contract is signed. Border-zone rules and processing times vary by neighbouring country and canton, so confirm the specifics with Basel's cantonal migration office or with HR during the application.
How do I apply for this position at Coopers Group AG?
Use the "Apply now" button on this page — it links directly to Coopers Group AG's original listing at coopers.ch, so your application goes straight to the employer's own applicant-tracking system. Frontaliere Ticino does not collect or forward applications itself.
