Quality Assurance Technician

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

YOUR MISSION

Reporting to the QA Department Leader, the Quality Assurance Technician is responsible for managing and overseeing the company’s documentation system in compliance with ISO 13485 standards. This includes ensuring the proper creation, revision, approval, distribution, and archiving of all quality-related documents, as well as maintaining the integrity and security of controlled documentation to support the organization’s quality management system (QMS). The role plays a critical part in ensuring that all documentation meets regulatory, customer, and internal requirements within the medical device industry.

As part of this team, your main responsibilities will include:

Document Control Management:
• Manage the document control system, including document creation, review, approval, distribution, and retrieval processes, in compliance with ISO 13485 requirements. • Ensure that all documents are maintained according to the company's quality management system (QMS).
• Establish and enforce version control to maintain accurate and up-to-date documents.
• Control the distribution of quality documentation to relevant personnel or departments, ensuring they have access to the most current version.
Document Creation and Revision:
• Collaborate with department heads and subject matter experts to create and update standard operating procedures (SOPs), work instructions, forms, policies, and other controlled documents.
• Review documents for consistency, accuracy, and compliance with internal and regulatory standards.
• Facilitate and coordinate document review and approval workflows, ensuring timely completion.
ISO 13485 Compliance:
• Ensure that all documentation is maintained in compliance with ISO 13485, FDA 21 CFR Part 820, and other applicable regulatory requirements.
• Support internal and external audits by providing required documentation and ensuring all records are up-to-date and compliant.
• Conduct regular document audits to ensure compliance with company policies and regulatory requirements.
Training and Support:
• Provide training and guidance to employees on document control procedures and compliance with ISO 13485 requirements.
• Serve as the primary point of contact for document control issues and inquiries from internal teams and external auditors.
Record Management:
• Implement and maintain a secure system for archiving and retaining quality records according to regulatory and company retention policies.
• Ensure the protection and confidentiality of all controlled documents, both digital and physical.
Participate in continuous improvement initiatives aimed at streamlining document control processes and enhancing QMS efficiency.

YOUR COMPETENCIES

• Bachelor’s degree in a related field (Quality Assurance, Life Sciences, Engineering, etc.) or equivalent experience.
• Minimum of 2-3 years of experience in a document control or quality assurance role within an ISO 13485 GMP or 21CFR part 820 - compliant environment, preferably in the medical device or pharmaceutical industry.
• Experience with document management systems (DMS) and electronic quality management systems (eQMS). • Strong attention to detail and organizational skills.
• Ability to analyse information in a structured manner and prepare coherent reports.
• Ability to build and present structured rationale to support business processes.
• Excellent communication skills, both written and verbal and ability to demonstrate a collaborative approach.
• Ability to work independently and manage multiple tasks in a fast-paced environment.
• Proficiency in Microsoft Office and document management software.
• 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.