Junior Quality Operations Engineer – Validation Specialist Ne

Junior Quality Operations Engineer – Validation Specialist
Ne
Liguria, Ne

Junior Quality Operations Engineer – Validation Specialist We offer an interesting opportunity to join our Quality Operations team, based in Bussolengo (VR) as Junior Quality Operations Engineer – Validation Specialist , reporting to the Quality Operations Manager.

In this position you will focus on validation activities related to internal manufacturing processes.

Responsibilities include developing and executing validation protocols (IQ, OQ, PQ), maintaining the Validation Master Plan, conducting risk analyses (pFMEA), and utilizing statistical techniques to ensure compliance and process quality.

You will also support other quality-related activities, such as process monitoring, deviation management, and implementation of corrective and preventive actions.

You will deal with other company departments and suppliers, distributors, laboratories and consultants.

Especially in particular R&D, Process Engineering, Quality Engineering, International Supply Chain, Regulatory.

What will your contribution be?

Develop and execute validation protocols (IQ, OQ, PQ) for equipment, processes, and systems to ensure compliance with company and regulatory standards.

Manage, update, and maintain the Validation Master Plan (VMP) to align with internal and external requirements.

Perform risk analyses of manufacturing processes using tools such as pFMEA (Process Failure Mode and Effects Analysis) to identify and mitigate potential risks Apply statistical techniques to analyze validation data and support data-driven decision-making.

Maintain and update validation documentation, including protocols, reports, and standard operating procedures (SOPs), ensuring alignment with quality management standards.

Support quality-related activities for internal manufacturing processes, such as process monitoring, deviation management, and implementation of corrective and preventive actions Assist in ensuring compliance with applicable regulations, including GMP (Good Manufacturing Practices), ISO standards, and other relevant guidelines.

Collaborate with cross-functional teams to address validation and quality concerns effectively.

What are we looking for?

Master's degree in mechanical or biomedical engineering or similar is preferred A previous experience of 2 years, preferably in the medical device industry or other regulated environments Excellent English written and spoken required Proficiency in general Office applications (especially Microsoft Excel, Microsoft Word and Microsoft Power Point).

Familiarity with statistical software like Minitab is highly recommended.

What soft skills are we looking for?

Problem solving Excellent written and verbal communication skills, with the ability to work effectively in cross-functional team Ability to work in team Familiarity with quality standards and regulations such as ISO 13485 and ISO 9001 (preferred) Strong analytical skills, with experience in risk assessment and root cause analysis.

Knowledge of statistical methods and tools used in validation processes Attention to detail, organizational skills, and a proactive approach to problem-solving What will you find?

Friendly, warm, and innovative atmosphere Healthy, inspiring, and international and inclusive work environment Training and development opportunities Competitive reward packages Social and company events Wellbeing initiatives (welfare) Canteen Benefits (Pension Fund- Health Insurance) What we offer?

This is a full-time job The contract is a permanent contract Salary package range: 32. 000/35. 000€* *please note that this is a range; the complete salary package will be defined based on the seniority / skills of the person