PWe offer an interesting opportunity to join our strongQuality Operations /strongteam, based in Bussolengo (VR) as strongQuality Operations Engineer /strong, reporting to the Quality Operations Manager, on a full-time permanent contract. /ppbr/ppAs 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. /ppbr/ppWorking 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. /ppbr/ppstrongWhat will your contribution be? /strong /ppbr/pulliSupport the validation of manufacturing processes for finished goods, components, and subassemblies, including the definition and execution of validation protocols and reports. /liliPerform statistical analyses (e.g. process capability studies) to assess and monitor production process performance. /liliDefine and maintain control plans for internal processes, specifying inspection/test methods and frequencies based on risk assessments. /liliConduct and maintain pFMEA (process Failure Modes and Effects Analysis) to identify process risks and define adequate control strategies. /liliInvestigate internal process non-conformities, lead root cause analyses, and implement effective corrective and preventive actions. /liliEvaluate and approve rework procedures for non-conforming products or components. /liliEnsure cleanroom operations are compliant with internal procedures and environmental standards through regular checks and coordination with relevant teams. /liliCollaborate with cross-functional teams to drive continuous improvement initiatives across production processes. /liliSupport third-party and internal audits by preparing and presenting documentation related to internal process quality. /liliParticipate in change control activities related to internal manufacturing processes, providing quality impact assessments. /li /ulpbr/ppstrongWhat are we looking for? /strong /ppbr/pulliPreferred technical degree or master’s degree in Engineering, Life Sciences, or related technical discipline. /liliA previous experience of 2/3 years in a similar role is required, preferably in a regulated industry (medical device, pharmaceutical, automotive). /liliAdvanced knowledge of English and Italian /liliGood knowledge of Microsoft office /liliSolid understanding of quality principles and statistical analysis (e.g. Cp/Cpk, SPC). /liliHands-on experience with process validation, control plan development, and pFMEA. /liliKnowledge of root cause analysis and problem-solving methodologies (5 Why, Fishbone, 8D). /liliFamiliarity with cleanroom operations and environmental control requirements, including contamination prevention measures and personnel/material flow. /liliUnderstanding of microbiological testing such as bioburden, LAL (Limulus Amebocyte Lysate), and environmental monitoring in controlled environments. /liliFamiliarity with ISO 13485, ISO 9001, and 21 CFR Part 820 standards. /liliStrong analytical mindset, attention to detail, and ability to manage multiple priorities. /liliGood interpersonal skills and ability to work in cross-functional teams. /liliFamiliarity with statistical software like Minitab is highly recommended. /li /ulpbr/ppstrongWhat soft skills will you improve? /strong /ppbr/pulliAbility to work precisely according to procedures, rules, and regulations /liliStrong analytical mindset, attention to detail, and ability to manage multiple priorities. /liliGood interpersonal skills and ability to work in cross-functional teams. /liliAdherence to timelines and result result-oriented attitude /liliOrderliness and attention to detail /liliAccountability for the assigned tasks /li /ulpbr/ppstrongWhat will you find? /strong /ppbr/pulliFriendly, warm, and innovative atmosphere /liliHealthy, inspiring, and international and inclusive work environment /liliTraining and development opportunities /liliSmart working model (two days per week) /liliCompetitive reward packages /liliSocial and company events /liliWellbeing initiatives (welfare) /liliCanteen /liliBenefits (Pension Fund- Health Insurance) /li /ulpbr/ppstrongWhat we offer? /strong /ppbr/pulliThis is a full-time job /liliThe contract is a permanent contract /liliSalary package range: 35.000/40.000 euro* /li /ulp*The package will be evaluated based on the experience of the person /p