Quality Engineer

OverviewThe Quality Operations Engineer ensures compliance with regulatory standards and internal quality systems throughout the manufacturing process of medical devices.This role focuses on maintaining product integrity, supporting production teams, and driving continuous improvement initiatives to meet ISO ***** and other applicable regulations.Responsibilities include monitoring in-process quality, investigating non-conformances, implementing corrective and preventive actions (CAPA), and collaborating with cross-functional teams to optimize processes.Job ResponsibilitiesQuality Management System (QMS) Oversight, Develop, implement, and maintain quality policies, initiatives, and procedures to ensure full compliance with ISO *****.Process & Product Monitoring, Define, measure, and analyze key performance indicators (KPIs) to monitor product performance and identify opportunities for continuous improvement.Quality Control, provide engineering support to define and implement in-process and incoming inspection requirements and establish quality control measures, including testing protocols.Root Cause Analysis & Corrective Actions, Lead cross-functional teams in root cause analysis, and implement corrective and preventive actions to resolve quality issues.Risk Management, Lead in risk management activities, identifying and mitigating potential quality risks throughout the product lifecycle such as PFMEA.Quality technical compliance with ISO ****, Stay updated on relevant industry regulations and standards, such as ISO ***** and FDA regulations.Documentation and Record Keeping, Ensure all quality-related activities, processes, and documentation are maintained and documented consistently.Plan and Implement calibration, Develop and implement a comprehensive calibration plan, including schedules, timelines, and procedures for calibrating monitoring and measuring equipment.Ensure Equipment Accuracy, Verify that all equipment used for medical device manufacturing is calibrated and verified at specified intervals or before use, maintaining records of these activities.Maintain Records, Keep accurate, complete, and readily available records of all calibration and verification activities, including equipment details, calibration results, and the personnel who performed them.Manage Calibration Status, Use calibration status labels to clearly identify the calibration date and due date of instruments, providing a control mechanism to ensure only calibrated equipment is used.Handle Deviations and Non-Conformance, Create plans and procedures for managing situations where equipment is found to be out of calibration, including taking corrective actions such as adjustment, re-calibration, or replacement.Manage Certificates, Review calibration certificates carefully and ensure they are approved and signed by the process owner and stored appropriately.Education and ExperienceExperience on FMEA, MSA and manufacturing processesStatistical knowledge with six sigma approach; English language at least B2 level due to the international environmentBachelor's degree in scientific or engineering discipline (e.g., mechanical, biomedical, electrical)Knowledge and SkillsISO ***** and **** Expertise, Deep understanding of the standard's requirements for medical device quality management systemsQMS Knowledge, Proficiency in establishing, maintaining, and improving a Quality Management System (QMS) in compliance with ISO *****Regulatory Compliance, Knowledge of other relevant regulations, such as FDA 21 CFR 820 and the European Medical Device Regulation (MDR)Communication, Effective communication skills to keep the complainant informed, provide updates, and communicate with regulatory bodies.Product Knowledge, A solid understanding of the medical device or service in question to accurately assess the complaint further to a deep knowledge of their process for manufacturingCritical Thinking & Problem-Solving, The ability to analyze situations, assess risks, and find appropriate solutions to complex issuesAttention to Detail, A high level of focus on detail to ensure accuracy in documentation, inspections, and process adherence.Teamwork, Ability to collaborate effectively with cross-functional teams to achieve common quality goals.Leadership, Skills to take ownership, drive initiatives, and mentor others in quality best practices.Project Management, Ability to manage and lead quality projects from conception to completion, ensuring deadlines and quality standards are metThis announcement is addressed to both sexes, in according to laws ********, and to people of all ages and all nationalities, pursuant to legislative decrees ****** and ******#J-*****-Ljbffr