Panda International
jobid=A.0.0313
pWe are seeking a Quality Assurance Specialist to join a fast-paced and quality-driven medical device environment based in Flevoland, Netherlands. The ideal candidate will have deep expertise in ISO 13485, MDR and CAPA systems, with a passion for maintaining and enhancing Quality Management Systems (QMS) across the product lifecycle. This role plays a critical part in supporting both compliance and continuous improvement initiatives, while actively collaborating with cross-functional teams to ensure product and process quality. /ppCompany Description: /ppOur client is a dynamic and innovative organization operating within the medical device industry, with a strong focus on the design, development, and production of Class III implantable devices. With full in-house manufacturing capabilities and a commitment to the highest standards of quality, they prioritize patient safety, product performance, and global regulatory compliance. /ppEssential Requirements: /pulliMinimum 2-3 years of experience in QA within medical device or other regulated life sciences sectors /liliStrong knowledge of ISO 13485 and EU MDR /liliProven experience leading and closing CAPAs using structured root cause analysis tools (e.g., 5 Whys, Fishbone) /liliExpertise in change control processes for engineering, manufacturing, and documentation /liliAbility to review and approve technical documentation, including SOPs, batch records,and validation reports /liliSkilled in internal audits and confident in supporting external inspections (e.g., Notified Body audits) /liliHands-on experience working in cleanroom manufacturing environments /liliSolid technical writing skills and proficiency in Microsoft Office Suite /liliProfessional-level English language proficiency /li /ulpNext Steps: /ppIf you’re ready to take the next step in your Quality Assurance career and contribute to an innovative medical device organization, we would love to hear from you. Apply today to express your interest – interviews are being scheduled on a rolling basis, so early applications are strongly encouraged. /ppFor more information or a confidential conversation about this opportunity, please don’t hesitate to get in touch. Contact Aimee Brener at /p
