Sr. Quality Engineer, Design Assurance

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7kq5hr

ph3Why Orthofix? /h3pGuided by our organizational values – Take Ownership | Innovate Boldly | Win Together – 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 unrivaled partner in Med Tech. Our 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. We offer an interesting opportunity to join our Quality Engineering team, based in Bussolengo (VR) as Sr. Quality Engineer, Design Assurance, reporting to the Quality Engineering Manager , on a maternity substitution contract. /ph3What will your contribution be? /h3ulliManage (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. /liliManage (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; Cooperate 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.



/liliSupport 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. /liliCooperate 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; Support the RD Area to formalize: Product requirements definition and review; Project development plan; Produce development phase gate documentation; Design verification documentation. /liliImplement and update internal procedures relevant to the above mentioned activities. /liliSupport the preparation and review of product technical marketing sheets. /liliTravel may be needed (10%-15%) /li /ulh3What are we looking for? /h3ulliPreferred technical degree or master's degree. /liliA previous experience of 2/3 years in a similar role is required, preferably in a regulated industry (medical device). /liliAdvanced knowledge of English and Italian. /liliMethodical and critical thinking. /liliExcellent organizational and project management skills. /liliProblem solving skills and proactivity. /liliAbility to work according to procedures, rules and regulations. /liliAdherence to timelines and result oriented attitude. /liliPrecision and attention to detail.



/liliAnalytical approach to resolve complex issues. /liliAbility to work in team and autonomously. /liliAccountability for the assigned tasks. /liliKnowledge of relevant regulations (European MDD, MDR, FDA Guidances, ISO 13485, ISO 14971, EN 62366, IEC 62304, IEC 6061, etc.). /liliKnowledge of relevant standards and application regarding biocompatibility, sterilization, reprocessing and cleaning. /li /ulh3What soft skills will you improve? /h3ulliAbility to work precisely according to procedures, rules, and regulations. /liliAnalytical mindset, attention to detail, and ability to manage multiple priorities. /liliGood interpersonal skills and ability to work in cross-functional teams. /liliAdherence to timelines and result result-oriented attitude. /liliOrderliness and attention to detail. /liliAccountability for the assigned tasks. /li /ulh3What will you find? /h3ulliFriendly, warm, and innovative atmosphere. /liliHealthy, inspiring, and international and inclusive work environment. /liliTraining and development opportunities. /liliSmart working model (two days per week). /liliCompetitive reward packages. /liliSocial and company events. /liliWellbeing initiatives (welfare). /liliCanteen Benefits (Pension Fund- Health Insurance). /liliWorking Hours: 8:30-17:30 Monday to Thursday and 8:30-16:30 Friday. /liliLocation: Bussolengo (VR). /liliContract type: full-time, maternity substitution contract. /liliSalary package range: 40.000/43.000 euro* (The package will be evaluated based on the experience of the person). /li /ulh3What we offer? /h3pThis is a full-time job. The contract is a maternity substitution contract. /p /p #J-18808-Ljbffr

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7kq5hr