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Quality Technician

Michael Page

Tipo di contratto
Contratto
Luogo
Lausanne
Prima pubblicazione
Candidati ora
• Contribute to life-changing healthcare technologies that improve patient outcome • Join an innovative international environment with strong quality About Our Client ## Our client is an innovative medical technology company dedicated to developing breakthrough solutions that improve the lives of people facing significant health challenges. They foster a collaborative, mission-driven culture where innovation, quality, and patient impact are at the heart of everything they do. Job Description ## • Collaborate with contract manufacturers and suppliers to ensure quality requirements are met throughout the product lifecycle. • Review and approve manufacturing batch records to ensure compliance with specifications, GMP requirements, and internal procedures. • Support incoming inspection activities, including review of Certificates of Analysis, inspection reports, and material certifications. • Assist with material disposition decisions and drive resolution of quality-related discrepancies. • Participate in nonconformance investigations, root cause analysis, and CAPA implementation. • Support equipment qualification and process validation activities (IQ/OQ/PQ) at supplier and manufacturing partner sites. • Support or lead batch release activities, including Device History Record reviews and verification of quality control results. • Work closely with Regulatory Affairs, Procurement, Manufacturing, and other cross-functional teams to ensure timely issue resolution and product release. • Participate in supplier audits, quality assessments, and continuous improvement initiatives. • 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. The Successful Applicant ## • 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's on Offer ## • 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. Quote job ref JN-072026-7053979 Job Function Healthcare & Life Sciences Specialisation Medical devices Industry Healthcare / Pharmaceutical Location Lausanne Region Contract Type Interim Job Reference JN-072026-7053979

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