Quality Technician

Michael Page is seeking a Quality Technician in Lausanne, CH, for a contract role. The position involves ensuring compliance with ISO 13485 and FDA regulations while collaborating with suppliers and cross-functional teams in a medical technology environment.

This position supports an innovative medical technology company dedicated to addressing health challenges through advanced solutions. The role focuses on maintaining high quality standards and driving continuous improvement within a collaborative, mission-driven environment that prioritizes patient impact.

Responsibilities

• Partner with contract manufacturers and suppliers to uphold quality standards across the entire product lifecycle.
• Examine and authorize manufacturing batch records to verify adherence to specifications, GMP rules, and internal protocols.
• Assist with incoming inspections by evaluating Certificates of Analysis, inspection reports, and material certifications.
• Help determine material dispositions and resolve quality-related discrepancies.
• Engage in nonconformance investigations, root cause analysis, and the implementation of corrective and preventive actions (CAPA).
• Support equipment qualification and process validation efforts (IQ/OQ/PQ) at supplier and manufacturing partner locations.
• Assist in or lead batch release processes, including Device History Record reviews and verification of quality control outcomes.
• Collaborate with Regulatory Affairs, Procurement, Manufacturing, and other teams to resolve issues promptly and ensure product release.
• Take part in supplier audits, quality assessments, and continuous improvement projects.
• Ensure compliance with ISO 13485, FDA regulations, MDR requirements, and company quality processes.
• Maintain accurate quality documentation and records according to established procedures and retention requirements.

Requirements

• Bachelor's degree in Engineering, Life Sciences, or a related technical discipline.
• 3-5 years of experience in Quality Assurance within the medical device, pharmaceutical, or another regulated industry.
• Strong knowledge of ISO 13485, FDA QSR, and GxP regulations.
• Experience working with external suppliers and CMOs.
• Familiarity with batch record review and product release processes.
• Experience managing nonconformances, CAPAs, and quality investigations.
• Understanding of equipment qualification, process validation, and risk-based quality approaches.
• Strong analytical, problem-solving, and decision-making abilities.
• Excellent communication and stakeholder management skills.
• Experience using electronic Quality Management Systems such as MasterControl, TrackWise, Veeva, or similar platforms.
• Ability to work effectively in a cross-functional and international environment.

What the company offers

• Opportunity to make a meaningful impact within an innovative and fast-growing medical technology environment.
• Exposure to cutting-edge products, international suppliers, and complex quality operations.
• Collaborative culture offering responsibilities and autonomy.

About the company

The company operates as an innovative medical technology firm focused on developing solutions for health challenges. It fosters a collaborative, mission-driven culture where innovation, quality, and patient impact are at the heart of everything they do.

• The company fosters a collaborative, mission-driven culture where innovation, quality, and patient impact are at the heart of everything they do.