Sr. Quality Engineer, Design Assurance

Orthofix

Bussolengo

Ibrido

EUR 40.000 - 43.000

Tempo pieno

9 giorni fa

Generatore di candidature

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Vantaggi offerti da questo lavoro

Canteen

Training and development

Smart working (two days per week)

Social events

Competitive compensation

International environment

Descrizione del lavoro

Orthofix, based in Bussolengo (VR), is hiring a Sr. Quality Engineer, Design Assurance to join the Quality Engineering team on a full‑time permanent contract.

You will liaise between Quality Compliance, QMS, R&D and Regulatory Affairs throughout product development and lifecycle, ensuring compliance with applicable standards and directives. You will lead Risk Management, usability validation, and regulatory release activities, while collaborating across departments to support post‑market

Competenze

Must have a technical degree or master’s degree.
2–3 years experience in a similar role.
Advanced knowledge of English and Italian.
Knowledge of regulations (MDD, MDR, ISO 13485, ISO 14971, etc.) and biocompatibility, sterilization standards.

Mansioni

Manage Risk Management activities during Product Development and post‑market surveillance.
Coordinate usability and design validation with R&D, Marketing, Medical Science and Clinical Evidence.
Coordinate regulatory release (CE Mark, FDA) for new products and modifications.
Support PSUR, PMCF, CER activities related to risk analysis and design validation.
Prepare regulatory submissions and Technical File documentation.

Conoscenze

English

Italian

Project management

Analytical thinking

Attention to detail

Team collaboration

Procedures compliance

Formazione

Master’s degree

Descrizione del lavoro

Guided 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 full time permanent contract.

As part of the Quality Team, you will be responsible for liasing between Quality Compliance, Quality Management System, Research & Development (R&D) Area and Regulatory Affairs Area during the Design & Development phase of products and their complete lifecycle, including post market surveillance and design changes.

You 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.

What will your contribution be?

Manage (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.
Manage (promote, coordinate and document), in cooperation with R&D, 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.
Support 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.
Cooperate 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 R&D Area to formalize: Product requirements definition and review; Project development plan; Produce development phase gate documentation; Design verification documentation.
Implement and update internal procedures relevant to the above mentioned activities.
Support the preparation and review of product technical & marketing sheets.
Travel may be needed (10%-15%)

What are we looking for?

Preferred technical degree or master’s degree.
A previous experience of 2/3 years in a similar role is required, preferably in a regulated industry (medical device).
Advanced knowledge of English and Italian
Methodical and critical thinking.
Excellent organizational and project management skills.
Problem solving skills and proactivity
Ability to work according to procedures, rules and regulations
Adherence to timelines and result oriented attitude
Precision and attention to detail
Analytical approach to resolve complex issues
Ability to work in team and autonomously
Accountability for the assigned tasks
Knowledge of relevant regulations (European MDD, MDR, FDA Guidances, ISO 13485, ISO 14971, EN 62366, IEC 62304, IEC 6061, etc.).
Knowledge of relevant standards and application regarding biocompatibility, sterilization, reprocessing and cleaning.

What soft skills will you improve?

Ability to work precisely according to procedures, rules, and regulations
Analytical mindset, attention to detail, and ability to manage multiple priorities.
Good interpersonal skills and ability to work in cross‑functional teams.
Adherence to timelines and result result‑oriented attitude
Orderliness and attention to detail
Accountability for the assigned tasks

What will you find?