ph3Role Overview /h3pWe offer an interesting opportunity to join our Quality Engineering team, based in Bussolengo (VR) as Junior Quality Engineer, Design Assurance reporting to the Quality Engineering Manager.
/ph3Key Responsibilities /h3ulliServe as the liaison between Quality Compliance, Quality Management System, RD and Regulatory Affairs during the Design Development phase and throughout the product lifecycle, including post?market surveillance and design changes.
/liliManage and coordinate Risk Management activities during Product Development and post?marketing surveillance.
/liliCoordinate and document usability and design validation activities, including participation in simulated use testing.
/liliCooperate with internal departments to secure regulatory release (CE Mark, FDA approval) for new products and modifications.
/liliSupport Quality Compliance and Clinical Evidence areas in Post?Market Surveillance: complaints analysis, PSUR, PMCF report and CER related to risk analysis, design validation and applicable standards.
/liliPrepare regulatory submissions (e.g., 510(k) pre?market notifications) and support all regulatory pre? and post?market activities; prepare Technical File documentation.
/liliAssist RD in formalizing product requirements definition and review, project development plan, develop gate documentation and design verification documentation.
/liliImplement and update internal procedures relevant to the above activities.
/liliSupport preparation and review of product technical and marketing sheets; contribute to Instructions for Use for new or modified products.
/liliPromote improvement initiatives, including corrective and preventive action (CAPA).
/liliSupport Customer Services and the Tender office with product?related declarations requested by customers or authorities.
/liliProvide support during audits/inspections by Notified Bodies or Regulatory Competent Authorities to maintain facility certifications.




/li /ulh3Qualifications /h3ulliTechnical degree in engineering or related field.
/lili1–2 years of experience in the medical device sector (preferred).
/liliFluent in English, written and oral.
/liliStrong ability to work according to procedures, rules and regulations.
/liliAdherence to timelines and result?oriented attitude.
/liliKnowledge of relevant regulations (European MDD, MDR, FDA guidance, ISO *****, ISO *****, EN *****, IEC *****, IEC ****, etc.).
/liliKnowledge of relevant standards and applications regarding biocompatibility, sterilization, reprocessing and cleaning.
/liliProficiency in Microsoft Office tools.
/liliWillingness to travel *****% if needed.
/li /ulh3Soft Skills /h3ulliMethodical and critical thinking.
/liliGood organizational and project?management skills.
/liliProblem?solving skills and proactivity.
/liliPrecision and attention to detail.
/liliAbility to work in a team and autonomously.
/liliAccountability for assigned tasks.
/li /ulh3Benefits and Compensation /h3ulliFriendly, warm, and innovative atmosphere.
/liliHealthy, inspiring, 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).
Canteen.
/liliBenefits: Pension Fund, Health Insurance.
/liliFull?time job.
Working hours: 8:*****:30 Monday–Thursday, 8:*****:30 Friday.
/liliContract: maternity substitution.
/liliSalary range: €35,000 – €40,000.
/li /ulh3Equal Employment Opportunity /h3pWe are committed to providing equal employment opportunities to all employees and applicants without regard to race, ethnicity, religion, gender, sexual orientation, or any other protected status in accordance with applicable federal, state, and local laws.
This policy extends to all aspects of our employment practices.
/p /p #J-*****-Ljbffr

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