Quality Operations Engineer

We offer an interesting opportunity to join our Quality Operations team, based in Bussolengo (VR) as Quality Operations Engineer , reporting to the Quality Operations Manager, on a full-time permanent contract.

As part of the Quality Team, you will be responsible for ensuring the quality and compliance of internal manufacturing processes, supporting their validation, monitoring, and continuous improvement. The role involves the analysis and control of production processes, the development of risk-based control strategies, and the management of internal non-conformities.

Working closely with Operations, Process Engineering, and R&D, this role ensures that manufacturing processes consistently produce products that meet quality, performance, and regulatory requirements. The Quality Operations Engineer also supports the maintenance of the cleanroom environment and contributes to the site’s overall quality system compliance.

What will your contribution be?

• Support the validation of manufacturing processes for finished goods, components, and subassemblies, including the definition and execution of validation protocols and reports.
• Perform statistical analyses (e.g. process capability studies) to assess and monitor production process performance.
• Define and maintain control plans for internal processes, specifying inspection/test methods and frequencies based on risk assessments.
• Conduct and maintain pFMEA (process Failure Modes and Effects Analysis) to identify process risks and define adequate control strategies.
• Investigate internal process non-conformities, lead root cause analyses, and implement effective corrective and preventive actions.
• Evaluate and approve rework procedures for non-conforming products or components.
• Ensure cleanroom operations are compliant with internal procedures and environmental standards through regular checks and coordination with relevant teams.
• Collaborate with cross-functional teams to drive continuous improvement initiatives across production processes.
• Support third-party and internal audits by preparing and presenting documentation related to internal process quality.
• Participate in change control activities related to internal manufacturing processes, providing quality impact assessments.

What are we looking for?

• Preferred technical degree or master’s degree in Engineering, Life Sciences, or related technical discipline.
• A previous experience of 2/3 years in a similar role is required, preferably in a regulated industry (medical device, pharmaceutical, automotive).
• Advanced knowledge of English and Italian
• Good knowledge of Microsoft office
• Solid understanding of quality principles and statistical analysis (e.g. Cp/Cpk, SPC).
• Hands-on experience with process validation, control plan development, and pFMEA.
• Knowledge of root cause analysis and problem-solving methodologies (5 Why, Fishbone, 8D).
• Familiarity with cleanroom operations and environmental control requirements, including contamination prevention measures and personnel/material flow.
• Understanding of microbiological testing such as bioburden, LAL (Limulus Amebocyte Lysate), and environmental monitoring in controlled environments.
• Familiarity with ISO 13485, ISO 9001, and 21 CFR Part 820 standards.
• Strong analytical mindset, attention to detail, and ability to manage multiple priorities.
• Good interpersonal skills and ability to work in cross-functional teams.
• Familiarity with statistical software like Minitab is highly recommended.

What soft skills will you improve?

• Ability to work precisely according to procedures, rules, and regulations
• Strong 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?

• Friendly, warm, and innovative atmosphere
• Healthy, inspiring, and 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)

What we offer?

• This is a full-time job
• The contract is a permanent contract
• Salary package range: Visualizzare il telefono su euspert.app euro*

*The package will be evaluated based on the experience of the person