Sr. Quality Engineer, Design Assurance
Pubblicato il 21-09-2026 - Orthofix in Bussolengo
ppGuided by our organizational values – bTake Ownership /b | bInnovate Boldly /b | bWin Together /b – we collaborate closely with world‑class surgeons and other partners to improve people’s quality of life. At Orthofix, we want team members who build relationships and share knowledge, challenge the status quo, and deliver results every day to help us achieve our vision to be the bunrivaled /b partner in Med Tech. /p pOur global team of over 1,600 employees brings to market highly innovative, cost‑effective, and user‑friendly medical technologies that heal musculoskeletal pathologies for patients and the healthcare professionals who treat them. Looking to change people’s lives? Look no further. /p pWe offer an interesting opportunity to join our bQuality Engineering /b team, based in Bussolengo (VR) as bSr. Quality Engineer, Design Assurance /b, reporting to the Quality Engineering Manager , on a bfull time permanent /b contract. /p pAs part of the Quality Team, you will be responsible for liasing between Quality Compliance, Quality Management System, Research Development (RD) Area and Regulatory Affairs Area during the Design Development phase of products and their complete lifecycle, including post market surveillance and design changes. /p pYou will guarantee that Design Development activities are conducted in compliance with internal procedures and in conformity with standards, directives and laws applicable to the Organization. You will work in contact with Design Development Area coordinating specific activities like Risk Management process, design validation, usability and final release. /p h3What will your contribution be? /h3 ul liManage (i.e. promote, coordinate and document) the Risk Management activities during the Product Development Process, in relation to product modifications and during post‑marketing surveillance. /li liManage (promote, coordinate and document), in cooperation with RD, Marketing,
Medical Science and Clinical Evidence, the usability and design validation about new products, including partecipation to simulated use testing activities; /li liCooperate with internal departments during the Product Development Process to regulatory release (CE Mark, FDA approval) for: new products (standard products, small series, custom products);product modifications. /li liSupport Quality Compliance and Clinical evidence areas in the Post‑Market Surveillance activities providing contribution to complaints analysis, PSUR, PMCF report and CER in relation to risk analysis, design validation and applicable standards. /li liCooperate with Regulatory Affairs Area to prepare regulatory submissions (e.g. 510K pre‑market notifications), support all the regulatory pre- and post‑market activities related to technical aspects and prepare the Technical File documentation; /li liSupport the RD Area to formalize: Product requirements definition and review; Project development plan; Produce development phase gate documentation; Design verification documentation. /li liImplement and update internal procedures relevant to the above mentioned activities. /li liSupport the preparation and review of product technical marketing sheets. /li liTravel may be needed (10%-15%) /li /ul h3What are we looking for? /h3 ul liPreferred technical degree or master’s degree. /li liA previous experience of 2/3 years in a similar role is required, preferably in a regulated industry (medical device).
/li liAdvanced knowledge of English and Italian /li liMethodical and critical thinking. /li liExcellent organizational and project management skills. /li liProblem solving skills and proactivity /li liAbility to work according to procedures, rules and regulations /li liAdherence to timelines and result oriented attitude /li liPrecision and attention to detail /li liAnalytical approach to resolve complex issues /li liAbility to work in team and autonomously /li liAccountability for the assigned tasks /li liKnowledge of relevant regulations (European MDD, MDR, FDA Guidances, ISO 13485, ISO 14971, EN 62366, IEC 62304, IEC 6061, etc.). /li liKnowledge of relevant standards and application regarding biocompatibility, sterilization, reprocessing and cleaning. /li /ul h3What soft skills will you improve? /h3 ul liAbility to work precisely according to procedures, rules, and regulations /li liAnalytical mindset, attention to detail, and ability to manage multiple priorities. /li liGood interpersonal skills and ability to work in cross‑functional teams. /li liAdherence to timelines and result result‑oriented attitude /li liOrderliness and attention to detail /li liAccountability for the assigned tasks /li /ul h3What will you find? /h3 ul liFriendly, warm, and innovative atmosphere /li liHealthy, inspiring, and international and inclusive work environment /li liTraining and development opportunities /li liSmart working model (two days per week) /li liCompetitive reward packages /li liSocial and company events /li liCanteen /li liBenefits (Pension Fund- Health Insurance) /li liWorking Hours: 8:30-17:30 Monday to Thursday and 8:30-16:30 Friday. /li /ul h3What we offer? /h3 ul liThis is a full-time job /li liThe contract is a tempo pieno contract /li liSalary package range: 40.000/43.000 euro* /li liThe package will be evaluated based on the experience of the person /li /ul h3Do you want to join us? Are you ready to make a difference? /h3 /p #J-18808-Ljbffr