We offer an interesting opportunity to join our Quality Operations team, based in Bussolengo (VR) as a Quality Operations Engineer.
This is a full?time, permanent contract reporting to the Quality Operations Manager.About the roleAs part of the Quality Team, you will ensure the quality and compliance of internal manufacturing processes, supporting their validation, monitoring, and continuous improvement.
You will analyze and control production processes, develop risk?based control strategies, and manage internal non?conformities.Key ResponsibilitiesSupport 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 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 comply 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.QualificationsPreferred technical degree or master's degree in Engineering, Life Sciences,



or a related technical discipline.Previous experience of 2–3 years in a similar role, 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, and environmental monitoring in controlled environments.Familiarity with ISO *****, ISO ****, 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.Soft SkillsAbility to work precisely according to procedures, rules, and regulations.Strong analytical mindset and attention to detail.Good interpersonal skills and ability to work in cross?functional teams.Adherence to timelines and result?oriented attitude.Accountability for the assigned tasks.Benefits & Work EnvironmentFriendly, warm, and innovative atmosphere.Healthy, inspiring, international and inclusive work environment.Training and development opportunities.Lavoro da remoto model (two days per week).
Competitive reward packages.Social and company events.Wellbeing initiatives and welfare programs.Canteen access.Benefits: Pension Fund and Health Insurance.Salary package range: €35,000 – €40,000 (evaluated based on experience).
Location: Teramo, IT.
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📌 Quality Operations Engineer - €35.000 - €40.000 A Year (Teramo)
🏢 Orthofix
📍 Teramo