Junior Quality Engineer, Design Assurance

Role Overview

We 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.

Key Responsibilities

• Serve as the liaison between Quality Compliance, Quality Management System, R&D and Regulatory Affairs during the Design & Development phase and throughout the product lifecycle, including post‑market surveillance and design changes.
• Manage and coordinate Risk Management activities during Product Development and post‑marketing surveillance.
• Coordinate and document usability and design validation activities, including participation in simulated use testing.
• Cooperate with internal departments to secure regulatory release (CE Mark, FDA approval) for new products and modifications.
• Support 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.

• Prepare regulatory submissions (e. g., 510(k) pre‑market notifications) and support all regulatory pre‑ and post‑market activities; prepare Technical File documentation.
• Assist R&D in formalizing product requirements definition and review, project development plan, develop gate documentation and design verification documentation.
• Implement and update internal procedures relevant to the above activities.
• Support preparation and review of product technical and marketing sheets; contribute to Instructions for Use for new or modified products.
• Promote improvement initiatives, including corrective and preventive action (CAPA).
• Support Customer Services and the Tender office with product‑related declarations requested by customers or authorities.
• Provide support during audits/inspections by Notified Bodies or Regulatory Competent Authorities to maintain facility certifications.

Qualifications

• Technical degree in engineering or related field.
• 1–2 years of experience in the medical device sector (preferred).
• Fluent in English, written and oral.
• Strong ability to work according to procedures, rules and regulations.
• Adherence to timelines and result‑oriented attitude.
• Knowledge of relevant regulations (European MDD, MDR, FDA guidance, ISO 13485, ISO 14971, EN 62366, IEC 62304, IEC 6061, etc.).
• Knowledge of relevant standards and applications regarding biocompatibility, sterilization, reprocessing and cleaning.
• Proficiency in Microsoft Office tools.
• Willingness to travel 10–15% if needed.
• Soft Skills
• Methodical and critical thinking.
• Good organizational and project‑management skills.
• Problem‑solving skills and proactivity.
• Precision and attention to detail.
• Ability to work in a team and autonomously.
• Accountability for assigned tasks.

Benefits and Compensation

• Friendly, warm, and innovative atmosphere.
• Healthy, inspiring, international and inclusive work environment.
• Training and development opportunities.
• Smart working model (two days per week).
• Competitive reward packages.
• Social and company events.
• Wellbeing initiatives (welfare). Canteen.
• Benefits: Pension Fund, Health Insurance.
• Full‑time job. Working hours: 8:30–17:30 Monday–Thursday, 8:30–16:30 Friday.
• Contract: maternity substitution.
• Equal Employment Opportunity

We 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.

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