ppbWhy Orthofix? /bbr/ /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. /ppOur 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. /ppWe offer an interesting opportunity to join our bQuality Engineering /b team, based in Bussolengo (VR) as bJunior Quality Engineer, Design Assurance /b reporting to the bQuality Engineering Manager. /b /ppYo will be the liaison 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. br/You must guarantee that Design Development activities are conducted in compliance with internal procedures and in conformity with standards, directives and laws applicable to the Organization. /ppYou will work strictly in contact with Design Development Area coordinating specific activities like Risk Management process, design validation, usability and final release. /ppbWhat will your contribution be? /b /pullipManage (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. /p /lilipManage (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. /p /lilipCooperate with internal departments during the Product Development Process to the regulatory release (CE Mark, FDA approval) for: /p /lilipSupport 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.



/p /lilipCooperate 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; /p /lilipSupport the RD Area to formalize: /p /lilipImplement and update internal procedures relevant to the above mentioned activities. /p /lilipSupport the preparation and review of product technical marketing sheets. /p /lilipContribute to the preparation of Instructions For Use for new or modified products. /p /lilipPromote improvement initiatives, including the implementation of corrective and preventive action. /p /lilipSupport Customer Services and the Tender office by supplying product related declarations requested from customers or Authorities /p /lilipProvide support during audits/inspections carried out by Notified Body or Regulatory Competent Authorities to achieve and maintain facility certifications. /p /li /ulpbWhat are we looking for? /b /pullipTechnical degree /p /lilip1–2 years of experience in the medical device sector is preferred /p /lilipFluent English, both written and oral /p /lilipAbility to work according to procedures, rules and regulations /p /lilipAdherence to timelines and result oriented attitude /p /lilipKnowledge of relevant regulations (European MDD, MDR, FDA Guidances, ISO 13485, ISO 14971, EN 62366, IEC 62304, IEC 6061, etc.). /p /lilipKnowledge of relevant standards and application regarding biocompatibility, sterilization, reprocessing and cleaning. /p /lilipGood knowledge and understanding of Microsoft Office Tools. /p /lilipTravel 10-15% if needed /p /li /ulpbWhat soft skills will you improve? /b /pullipMethodical and critical thinking. /p /lilipGood organizational and project management skills. /p /lilipProblem solving skills and proactivity /p /lilipPrecision and attention to detail /p /lilipAbility to work in team and autonomously /p /lilipAccountability for the assigned tasks /p /li /ulpbWhat will you find? /b /pullipFriendly, warm, and innovative atmosphere /p /lilipHealthy, inspiring,



and international and inclusive work environment /p /lilipTraining and development opportunities /p /lilipSmart working model (two days per week) /p /lilipCompetitive reward packages /p /lilipSocial and company events /p /lilipWellbeing initiatives (welfare) /p /lilipCanteen /p /lilipBenefits (Pension Fund- Health Insurance) /p /li /ulpbWhat we offer? /b /pullipThis is a full-time job, working Hours: 8:30-17:30 Monday to Thursday and 8:30-16:30 Friday. /p /lilipThe contract is a maternity substitution /p /lilipSalary package range: 35.000/40.000 euro /p /li /ulpbDISCLAIMER /b /ppThe duties listed above are intended only as representation of the essential functions of this position. The omission of specific statements of duties does not exclude them from the position if the work is similar, related, or a logical assignment to the position. The job description does not constitute an employment agreement between the employer and employee and is subject to change at the sole discretion of the employer. Nothing in this document alters an employee’s at-will employment status. /ppWe are committed to providing equal employment opportunities to all employees and applicants without regard to race (including traits historically associated with race, such as hair texture and protective hairstyles, including braids, locks, and twists), ethnicity, religion, religious creed (including religious dress and grooming practices), color, caste, sex (including childbirth, breast feeding, and related medical conditions), gender, gender identity or expression, sexual orientation, national origin, ancestry, citizenship status, uniform service member and veteran status, marital status, pregnancy, age (40 and over), protected medical condition (including cancer and genetic conditions), genetic information, disability (mental and physical), reproductive health decision-making, medical leave or other types of protected leave (requesting or approved for leave under the Family and Medical Leave Act or the California Family Rights Act), domestic violence victim status, political affiliation, or any other protected status in accordance with all applicable federal, state, and local laws. /ppThis policy extends to all aspects of our employment practices including, but not limited to, recruiting, hiring, discipline, termination, promotions, transfers, compensation, benefits, training, leaves of absence, and other terms and conditions of employment. /p /p #J-18808-Ljbffr

📌 Junior Quality Engineer, Design Assurance (Bussolengo)
🏢 Orthofix
📍 Bussolengo