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מעל 90,000 משרות • אלפי משרות חדשות בכל יום
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Requisition ID: 74881Date: Jul 29, 2026Location:Shlomi, ISR, IL#job-location.job-location-inline { display: inline; }Department: QualityDescription:At West, we’re a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West’s indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future?There’s no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families.We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts.Job SummaryIn this onsite role, the Manufacturing Quality Engineer will own on all activities at one of sub-contractors, support the validation process to the contract manufacturing and provide quality oversight to the engineering department, while working within a multi-functional team environment for medical devices. The Manufacturing Quality Engineer will lead projects and tasks, from product validation through transfer to production and play an active role to ensure products meet quality standards consistent with internal procedures and acceptance criteria. Additionally, this role will identify and implement improvements to the production processes. The Manufacturing Quality Engineer will be the product and production focal point for our sub-contractors and will be responsible for projects related to production and machines, including training, audits, stop and renewing the production.Essential Duties and ResponsibilitiesExhibit a strong “quality first” mentality and ensure that product and quality are held to the highest standard.Meet company and departmental goals in the continuous improvement of all products, services and processes.Work cross-functionally with individuals or extended teams to provide guidance and ensure success of projects.Responsible to write, review and approve pilot documents (including reports).write and approve various department and production procedures and forms.Lead investigation processes for deviations and nonconformities in production and create analysis reports.Responsible for training the sub-contractors according QA procedures and VoE.Supports special processes such as sorting or rework in production.Own on all production activities at one of the subcontractors to ensure manufacturing is held according to West procedures and GMP/GDP standardsResponsible for stopping and renewing production with accordance to West requirements and with MQ manager approval.Manage production-related projects and act as MQ focal point in various internal and external projects- such as Data Integrity, CoPQ, production improvement plans, etc.Provide Quality oversight of validation activities and processes.Lead pilot processes which include change and approval of quality aspects in pilot protocols and reports and assure that pilot processes are conducted according to West guidance and protocols.Attend production pilot meetings as the MQ focal point.Essential Duties and Responsibilities:ProductionLead investigation processes for deviations and nonconformities in production and create analysis reports.Responsible for training the sub-contractors according QA procedures and VoE.Supports special processes such as sorting or rework in production.Own on all production activities at one of the subcontractors to ensure manufacturing is held according to West procedures and GMP/GDP standardsResponsible for stopping and renewing production with accordance to West requirements and with MQ manager approval.Manage production-related projects and act as MQ focal point in various internal and external projects- such as Data Integrity, CoPQ, production improvement plans, etc.Provide Quality oversight of validation activities and processes.Lead pilot processes which include change and approval of quality aspects in pilot protocols and reports and assure that pilot processes are conducted according to West guidance and protocols.Attend production pilot meetings as the MQ focal point.DelegationManufacturing Quality Manager or qualified Manufacturing QualityTeam Lead Manufacturing QualityEducationB.Sc. in Engineering or Science requiredWork ExperienceMinimum 3 years of experience in Medical Device Quality & ProductionifecycleRelevant work history and/or experience may be considered in lieu of degreeExperience with production processes and process controlsExperience with sub contractors interface and meeting customer expectationsExperience with Medical Device, Validation Activities, Risk Management, Product Transfer to productionWorking knowledge of quality systems such as ISO 13485, 21 CFR 820, ISO 14971, MDSAPPreferred Knowledge, Skills and AbilitiesMust have effective problem solving and interpersonal skillsAbility to work independently, multi-task and thrive in fast-paced environmentProblem solving including root cause failure analysis methodsExperience with Medical Device / Pharma- AdvantageValidation Activities, Risk Management, Product Transfer to productionWorking knowledge of quality systems such as ISO 13485, 21 CFR 820,SO 14971, MDSAPPhysical RequirementsLight-Exerting up to 20lbs/9kg of force frequently, and/or negligible amount of force frequently constantly to move objects.Additional RequirementsPrevious experience with MasterControl, Share Point, Teamcenter- a plusAdaptable to changes in the work environment, manage competing demands and deal with frequent change, delays or unexpected events.Must maintain the ability to work well with others in a variety of situationsMaintain high attention to detail, accuracy, and overall quality of workMust be able to multi-task, work under time constraints, problem solve, and prioritizeObserve and interpret situations, analyze and solve problemsEffectively communicate and interface with various levels internally and with customersCertified auditor- a plusRelevant work history and/or experience may be considered in lieu of degreeWest embraces diversity and equality of opportunity. We foster an environment where all individuals are safe, treated fairly, valued and respected. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, disability status or other applicable legally protected characteristics. Where permitted by law, employment with West Pharmaceutical Services, Inc. or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of post-offer background screening.#LI-KR1#LI -Onsite
במקום לעבור לבד על אלפי מודעות, Jobify מנתחת את קורות החיים שלך ומציגה לך רק משרות שבאמת מתאימות לך.
מעל 90,000 משרות • אלפי משרות חדשות בכל יום
חינם. בלי פרסומות. בלי אותיות קטנות.
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כבר העליתם קו"ח בעבר? כניסה
שאלות ותשובות עבור משרת Manufacturing Quality Engineer
מהנדס/ת איכות ייצור בחברת West Pharmaceutical Services אחראי/ת על כל הפעילויות אצל קבלני משנה, תמיכה בתהליכי ולידציה בייצור חוזי ופיקוח איכותי על מחלקת ההנדסה, תוך עבודה בסביבת צוות רב-תחומי עבור מכשור רפואי. התפקיד כולל הובלת פרויקטים ומשימות מוולידציית מוצר ועד העברה לייצור, הבטחת עמידת המוצרים בתקני איכות, וזיהוי ויישום שיפורים בתהליכי הייצור.
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