Senior Quality Assurance Manager (f/m/d)

Senior Quality Assurance Manager (f/m/d) – Engineering / IVD / German / GMP / ISO13485

Projekt:
For our client in the Roche Rotkreuz based in Rotkreuz we are looking for a Senior Quality Assurance Manager (f/m/d)

Background:
As part of the Product Quality Chapter within the Quality Assurance organization, the position holder provides support to the R&D teams within the Roche Information Solutions (RIS) organization. In particular, in the Design Quality Assurance activities for medical device standalone software. The Product Quality Chapter is composed by several Senior Quality Assurance Managers and some junior members of the team. 1 Quality Manager is located in Rotkreuz, the rest of the team is located in Sant Cugat (Spain)
The perfect candidate:
Digital and health combination plus Quality Assurance experience in a regulated environment (such as pharma, medical device, aerospace, automotive)
Having adequate criteria to make decisions based on Quality Assurance, software development process implementation and adoption of established regulatory requirements.
Good communication skills with the R&D team members such as Software Product Leader, Project Management, Product Risk Manager, etc.

Tasks & Responsibilities
* Represents Design Quality Assurance within the Global Q&R organization that supports the Roche Information Solutions (RIS) portfolio, which includes medical device standalone software, focusing on product quality and achieving sustainable compliance.
* Performs Quality activities as required to meet RIS Q&R goals and objectives independently and leads through the performance of these activities. Able to identify improvements and implement them. Participate in cross-functional Global initiatives.
* Covers tasks/projects with increased complexity and stakeholder management for the assigned software products project teams.
* Performs review and approval of design control documentation/deliverables for RIS medical device software during product development and product care activities. In particular for those software products within the Lab Insights customer area. Deliverables including Product Risk Assessment, Design Verification and Validation documentation, among others.
* Ensures that any design quality issues that may jeopardize the regulatory status of projects and products are handled with the necessary priority and urgency.
* Participates in the planning of design control deliverables and/or project team outputs. Supports design and milestone reviews.
* Supports actions regarding CAPAs to ensure compliance with internal and external requirements.
* Participates in the definition and implementation of meaningful KPIs to ensure product quality is instilled during the software development life cycle.
* Prepare documentation for and participate in quality audits and inspections as applicable.
* Responsible as a Product Quality Team Representative in the Product Care Team

Must Haves:
* Min. Bachelor or Advanced degree in science, software engineering, or a related field
* Min. 5+ years of experience as QA Manager in the digital health industry or a related field within Quality Assurance
* Experienced in software quality engineering, quality assurance within regulated industries (medical device / in-vitro diagnostics / pharma / automotive or aerospace)
* Experience within a project and on regards to the ISO standards in risk assessment and management for medical devices during the entire product lifecycle.
* Technical expertise in software, systems development and development tools
* Experienced in the implementation of enhancements of Design Controls, development methodologies, and tool capabilities
* Track record of building and nurturing capabilities such as design, provision, and maintenance of software systems for document and data change control, product release, and complaint handling for digital health products
* Knowledge in digital health standards and regulations: ISO 13485, 14971, IEC62304, 82304, 62366 and cybersecurity standards.
* English skills: fluent in spoken and written

Nice to Haves:
* German or Spanish is beneficial
* Previous Roche Diagnostic’s experience
* Experience of Software Development environment, especially R&D

Reference No.: 921400SGR
Role: Senior Quality Assurance Manager
Industry: Pharma
Location: Rotkreuz
Workload:100%
Start: 01.05.2022
Duration: 12++
Deadline: 21.04.2022

Should you find yourself suitable for this position then please send us your complete CV using the link in this advert. If the position is not a perfect match and you wish to receive other opportunities directly, you can send us your CV anyway via this advert or to jobs[at]itcag[dot]com.
Contact us for further information regarding our company, our positions or our attractive payroll-only-program: +41 41 760 77 01.

About us:ITech Consult is a certified ISO 9001:2015 Swiss company with offices also located in Germany and Ireland. ITech Consult is specialised in delivering IT and Life Science candidates for contract work. We were founded in 1997 by IT professionals; hence we well understand what it means to be professionally supported in your search for a new project and being employed.