Ph3Quality Operations Engineer – Bussolengo (VR) /h3 pWe offer an interesting opportunity to join our Quality Operations team as a Quality Operations Engineer, reporting to the Quality Operations Manager on a full‑time permanent contract. /p pAs 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. /p pWorking closely with Operations, Process Engineering, and RD, 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. /p h3What will your contribution be? /h3 ul liSupport the validation of manufacturing processes for finished goods, components, and subassemblies, including the definition and execution of validation protocols and reports. /li liPerform statistical analyses (e.g. process capability studies) to assess and monitor production process performance. /li liDefine and maintain control plans for internal processes, specifying inspection/test methods and frequencies based on risk assessments. /li liConduct and maintain pFMEA (process Failure Modes and Effects Analysis) to identify process risks and define adequate control strategies. /li liInvestigate internal process non‑conformities, lead root cause analyses, and implement effective corrective and preventive actions. /li liEvaluate and approve rework procedures for non‑conforming products or components. /li liEnsure cleanroom operations are compliant with internal procedures and environmental standards through regular checks and coordination with relevant teams. /li liCollaborate with cross‑functional teams to drive continuous improvement initiatives across production processes. /li liSupport third‑party and internal audits by preparing and presenting documentation related to internal process quality. /li liParticipate in change control activities related to internal manufacturing processes, providing quality impact assessments. /li /ul h3What are we looking for? /h3 ul liPreferred technical degree or master’s degree in Engineering, Life Sciences, or related technical discipline. /li liA previous experience of 2/3 years in a similar role is required, preferably in a regulated industry (medical device, pharmaceutical, automotive). /li liAdvanced knowledge of English and Italian /li liGood knowledge of Microsoft office /li liSolid understanding of quality principles and statistical analysis (e.g. Cp/Cpk, SPC). /li liHands‑on experience with process validation, control plan development, and pFMEA. /li liKnowledge of root cause analysis and problem‑solving methodologies (5 Why, Fishbone, 8D). /li liFamiliarity with cleanroom operations and environmental control requirements, including contamination prevention measures and personnel/material flow. /li liUnderstanding of microbiological testing such as bioburden, LAL (Limulus Amebocyte Lysate), and environmental monitoring in controlled environments. /li liFamiliarity with ISO 13485, ISO 9001, and 21 CFR Part 820 standards. /li liStrong analytical mindset, attention to detail, and ability to manage multiple priorities. /li liGood interpersonal skills and ability to work in cross‑functional teams. /li liFamiliarity with statistical software like Minitab is highly recommended. /li /ul h3What soft skills will you improve? /h3 ul liAbility to work precisely according to procedures, rules, and regulations /li liStrong analytical mindset, attention to detail, and ability to manage multiple priorities. /li liGood interpersonal skills and ability to work in cross‑functional teams. /li liAdherence to timelines and result result‑oriented attitude /li liOrderliness and attention to detail /li liAccountability for the assigned tasks /li /ul h3What will you find? /h3 ul liFriendly, warm, and innovative atmosphere /li liHealthy, inspiring, and international and inclusive work environment /li liTraining and development opportunitiesSmart working model (two days per week) /li liCompetitive reward packages /li liSocial and company events /li liCanteen /li liBenefits (Pension Fund- Health Insurance) /li /ul h3What we offer? /h3 ul liThis is a full‑time job /li liThe contract is a permanent contract /li liSalary package range: 35.000–40.000 euro* /li /ul p*The package will be evaluated based on the experience of the person /p /p #J-18808-Ljbffr