At AliveDx, we empower diagnostic insights, transform patient care, and innovate for life. With over 30-years in in-vitro diagnostics, we put the health of patients first by creating innovative solutions designed for faster diagnostic results. Alba–– our blood bank reagents portfolio–– and MosaiQ®–– one of the first multiplexing and multimodality automated testing platforms––are designed to make labs more efficient and clinical decision-making more effective. Our journey started as Alba Bioscience, and later, Quotient. Today, as AliveDx, we innovate for life.
AliveDx is seeking a Design Control and Risk Management Engineer to join our Design Control department based in Eysins, Switzerland. This is a full-time and permanent position.
YOUR MISSION
The Design Control and Risk Management Engineer is responsible for ensuring proper controls and quality of the design, development and life cycle process, with an emphasis on risk assessment protocols, providing direction and management of design quality related functions in the product life cycle.
Your main responsibilities will include:
- Accountable for the performance of the products and the resulting performance and quality
- Represent Design Quality on multi-disciplinary new product development and MOB teams. Work closely with the Research and Development and other cross functional teams involved in design and development phases to facilitate quality and regulatory compliance for:
o Design and Development Planning
o Design Requirements
o Design Outputs
o Design Verification
o Design documentation including review and approval.
o Design Review
o Design Transfer
o Maintain Design History File
o Risk management
o Monitoring and evaluation of Changes during the entire product life cycle
o Deviations management support during design phase
o Supplier Qualifications and support for Quality Agreements, as needed
o Definition of Process and Product Controls
- Determination of CTQ for process/ products
- Suitability of analytical methods
- Testing strategy for products and Stability program
o Validation including determination of strategy, documentation, and management of execution for
- Manufacturing Process
- Transport and packaging
- Analytical methods
- Support for new equipment qualification, as needed
- Recognised expert in Quality requirements with depth and breadth of experience in AliveDx’s processes, products, and their application
o Understand business processes / products and needs of internal / external customers and look to align service provided.
o Identify and drive improvement projects within the team to ensure continued and improved delivery.
- Act as a coach to support training and development of team members within a learning environment
o Interprets outputs of group operations as well as any practical-based training to increase understanding and knowledge across all team members.
o Collaborates across business and project groups and business units to ensure consistency of performance and to drive up knowledge of business operation and processes.
- Own Product Risk Management Process
o Ensure Product Risk Management Process is compliant with relevant Risk Management Regulations.
o Lead and/or support all types of Product Risk Management activities according to procedures in place.
o Ensure Product Risk Documentation is compliant with procedures in place.
o Ensure Product Risk Management Process efficiency according to KPIs set-up.
o Act as a Risk Management Team Representative during Third Party Audit.
o Promote risk culture including Risk Based Approach and Continuous Improvement.
o Provide Risk Management Training.
YOUR COMPETENCIES
- Degree or an equivalent Life Sciences qualification / degree
- Risk Management or Quality Systems / Engineering qualifications/training
- Minimum 5 years of experience in the Biotech/Pharma/Medical Devices industry
- Ideally experience in IVDR environment
- Expert knowledge and practical experience of CE and FDA regulations in a manufacturing environment
- Previous experience leading risk management activities
- Experience in product / process validation
- Knowledge of the IVD market in general and specific knowledge of clinical diagnostic products
- Ability to work under pressure, meet deadlines and respond flexibly
- Strong inter-personal skills
- Good attention to detail
- Fluent in English
- Ability to travel occasionally
WHAT WE OFFER
- A highly dynamic and growing environment.
- An opportunity to live your passion for an intrapreneurial mindset, where cultivating innovation and customer centricity are at the heart of everything we do.
- A flexible working environment where applicable and a range of core and flexible benefits, ranging from lunch allowance support, additional annual leave, cycle to work scheme, technology and access to marketplace discounts.
Interested? We invite you to send your application, including your resume and any other relevant documents. We look forward to exploring your potential contributions to AliveDx.
AliveDx is an equal opportunity employer and welcomes applications from all qualified individuals regardless of nationality, sex, disability, religion/belief, sexual orientation or age. All aspects of employment including the decision to hire, promote, discipline, or discharge, will be based on competences, performance and business needs.