AliveDx is seeking a Quality System Engineer to join our Quality Assurance department based in Eysins, Switzerland. This is a full-time and temporary position for 12 months.

YOUR MISSION
The Quality System Engineer will be firstly responsible for leading the successful implementation and transition of the company’s Quality Management System from a manual or legacy system to an electronic Quality Management System (eQMS) in compliance with ISO 13485 standards.
Then, the Quality System Engineer will be leading the integration of Medical Device Single Audit Program (MDSAP) requirements into the company’s existing Quality Management System (QMS), which complies with ISO 13485 standards. This position involves managing the project to ensure the organization meets the regulatory requirements of MDSAP-participating countries (e.g., USA, Canada, Brazil, Australia, and Japan) to reach the successful MDSAP certification.

The main responsibilities will more specifically include:

1) Key Responsibilities for eQMS transition:
Lead the end-to-end transition to an electronic Quality Management System (eQMS), ensuring alignment with ISO 13485 requirements.

Cross-Functional Collaboration:
• Work closely with IT, Quality Assurance, Regulatory Affairs, and other departments to ensure seamless integration of the eQMS with existing processes and systems. • Collaborate with stakeholders to gather requirements, define workflows, and ensure the eQMS meets regulatory, business, and user needs.

ISO 13485 and Regulatory Compliance:
• Ensure the eQMS meets ISO 13485, FDA 21 CFR Part 820, and other applicable medical device regulatory standards. • Oversee the validation and verification of the eQMS, including system qualification (IQ, OQ, PQ), user acceptance testing (UAT), and risk assessments.
• Ensure proper documentation and compliance records are maintained throughout the project, including design history files (DHF) and validation documentation.

Training and Change Management:
• Develop and implement a comprehensive training program for end users, ensuring staff are proficient in the use of the new eQMS and drive change management.

Vendor Management:
• Manage relationships with eQMS vendors, ensuring timely delivery of system components and services. • Ensuring the system meets quality, functionality, and budgetary requirements.

Risk and Issue Management:
• Identify potential project risks, develop mitigation strategies, and implement contingency plans to address unforeseen challenges. • Proactively manage issues related to system implementation, such as data migration, system customization, and integration with other business systems.

Continuous Improvement:
• Identify opportunities for process optimization within the QMS during the transition to eQMS. • Lead post-project reviews to evaluate the success of the transition and identify lessons learned for future quality system initiatives.

2) Key Responsibilities for MDSAP implementation:

• Lead the implementation of MDSAP requirements within the organization, ensuring full compliance with participating countries' regulations and alignment with ISO 13485.
• Develop and manage a detailed project plan outlining key milestones, timelines, resources, and deliverables for the MDSAP implementation process.
• Interpret MDSAP requirements and ensure they are integrated into the company’s QMS in compliance with ISO 13485 and local regulatory requirements (e.g., FDA, Health Canada, ANVISA, TGA, PMDA). • Oversee the creation or revision of Standard Operating Procedures (SOPs), work instructions, and other documentation to ensure compliance with MDSAP audit criteria.
• Work closely with departments such as Quality Assurance, Regulatory Affairs, Manufacturing, and Supply Chain to ensure MDSAP requirements are effectively implemented across all functions.
• Collaborate with external consultants or regulatory experts to support the MDSAP implementation and address complex regulatory requirements.

YOUR COMPETENCIES

• Bachelor’s degree in Quality assurance, Engineering, Life Sciences, Information Technology, or a related field and ideally advanced degree or certifications in Quality Management, Project Management (e.g., PMP), or Regulatory Affairs.
• Minimum of 5 years of experience in quality management or project management roles within an ISO 13485-compliant environment, preferably in the medical device or pharmaceutical industry.
• Strong understanding of ISO 13485, FDA 21 CFR Part 820, and other regulatory requirements for medical devices. • Experience in selecting, implementing, and validating eQMS platforms (e.g., MasterControl, TrackWise, or similar).
• Experience with validation and compliance of computerized systems (e.g., GAMP 5, 21 CFR Part 11).
• Demonstrated project management skills with the ability to manage large-scale, cross-functional projects.
• Strong knowledge of QMS processes such as CAPA, change control, document management, risk management, and audit management.
• Excellent communication, leadership, and interpersonal skills, with the ability to influence and collaborate with stakeholders at all levels.
• Proficiency in project management software and tools, as well as experience with electronic quality management systems (eQMS).
• Analytical and problem-solving skills with a focus on data-driven decision-making.
• Fluent in French and English.

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.