Descrizione dell'offerta
We are looking for a Quality R&D Lead to join our Quality R&D team in Milan, supporting our Drug Delivery Systems (DDS) Business Unit.
Key accountabilities
Act as Quality Lead in product development projects, ensuring design development and transfer to Operations follow Design Control principles.
Support the Design Team as quality and technical reference in key decisions.
Lead quality activities across product and process development, including design planning, inputs, outputs, verification, validation, and design transfer.
Review and approve Design Control documentation, DHF and Risk Management deliverables.
Act as Process Owner for Design & Development procedures, templates and tools.
Ensure correct application of procedures through training and continuous support to R&D teams.
Ensure risk management is fully integrated into Design Control processes, from user needs and design inputs through verification, validation, transfer, and post-market activities.
Lead change impact and risk assessments, supporting change approval and lifecycle change control.
Coordinate, Review and approve Risk Management File deliverables.
Collaborate with internal and external stakeholders to promote a strong and modern quality mindset.
Qualifications
5-8 years' experience in Quality Assurance R&D within Medical Device, Combination Product, Pharamceurical environments.
Strong knowledge of Design Control requirements (ISO 13485, FDA 21 CFR 820 / QMSR).
Strong knowledge and practical application of ISO 14971 Risk Management principles and methodologies.
Experience authoring and reviewing Risk Management Files and Design History Files
Familiarity with QMS and applicable standards and regulations.
Strong communication skills and ability to work cross-functionally.
Preferred Qualifications
Experience with drug delivery systems, combination products, or complex medical devices.
Experience integrating supplier risk assessments and external component risks into system-level risk evaluations.
Knowledge of Human Factors Engineering (IEC 62366), software risk management (IEC 62304), and cybersecurity risk management.
Experience participating in Notified Body and FDA inspections.
What We Offer
Comprehensive health and protection coverage, including supplementary health insurance and life insurance
Meal vouchers / canteen services, supporting your everyday experience at work
Access to our welfare platform, with flexible benefits to support wellbeing, family needs, and lifestyle choices
Continuous learning opportunities, including on-demand language training across a wide range of languages
For this role, the expected compensation range starts from € 43.000. The actual compensation will depend on a variety of job-related factors, including geographic location, professional experience, education, and skill level.
Our Commitment At Stevanato Group, we are committed to building a diverse and inclusive workplace, and we believe that potential, mindset, and motivation matter just as much as experience.
Quality R&D Lead - DDS&IVD Lombardy, Italy
#J-18808-Ljbffr
Key accountabilities
Act as Quality Lead in product development projects, ensuring design development and transfer to Operations follow Design Control principles.
Support the Design Team as quality and technical reference in key decisions.
Lead quality activities across product and process development, including design planning, inputs, outputs, verification, validation, and design transfer.
Review and approve Design Control documentation, DHF and Risk Management deliverables.
Act as Process Owner for Design & Development procedures, templates and tools.
Ensure correct application of procedures through training and continuous support to R&D teams.
Ensure risk management is fully integrated into Design Control processes, from user needs and design inputs through verification, validation, transfer, and post-market activities.
Lead change impact and risk assessments, supporting change approval and lifecycle change control.
Coordinate, Review and approve Risk Management File deliverables.
Collaborate with internal and external stakeholders to promote a strong and modern quality mindset.
Qualifications
5-8 years' experience in Quality Assurance R&D within Medical Device, Combination Product, Pharamceurical environments.
Strong knowledge of Design Control requirements (ISO 13485, FDA 21 CFR 820 / QMSR).
Strong knowledge and practical application of ISO 14971 Risk Management principles and methodologies.
Experience authoring and reviewing Risk Management Files and Design History Files
Familiarity with QMS and applicable standards and regulations.
Strong communication skills and ability to work cross-functionally.
Preferred Qualifications
Experience with drug delivery systems, combination products, or complex medical devices.
Experience integrating supplier risk assessments and external component risks into system-level risk evaluations.
Knowledge of Human Factors Engineering (IEC 62366), software risk management (IEC 62304), and cybersecurity risk management.
Experience participating in Notified Body and FDA inspections.
What We Offer
Comprehensive health and protection coverage, including supplementary health insurance and life insurance
Meal vouchers / canteen services, supporting your everyday experience at work
Access to our welfare platform, with flexible benefits to support wellbeing, family needs, and lifestyle choices
Continuous learning opportunities, including on-demand language training across a wide range of languages
For this role, the expected compensation range starts from € 43.000. The actual compensation will depend on a variety of job-related factors, including geographic location, professional experience, education, and skill level.
Our Commitment At Stevanato Group, we are committed to building a diverse and inclusive workplace, and we believe that potential, mindset, and motivation matter just as much as experience.
Quality R&D Lead - DDS&IVD Lombardy, Italy
#J-18808-Ljbffr
Candidatura e Ritorno (in fondo)
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