About us Your Contribution Own and control project scopes, schedules and budgets; manage risks/issues and communicate status to stakeholdersLead cross functional execution with Production, Quality, Maintenance, Supply Chain, EHS, and Global EngineeringManage CAPEX, PO releases, FAT/SAT planning, cost tracking/forecasting and accurals; deliver fiscal year plan on time and on budgetPrepare and maintain audit ready documentation aligned to US cGMPOperate in accordance with standard cleanroom conduct consistent with ISO 14644 practices and internal QMS and site Contamination Control StrategyOwn change controls (local and global)- initiaiton, risk assessment, execution plan, verification of effectivensss and closure Lead/support validation and qualification for equipment, products, processes, etc.Integrate into operations; plan trials and downtime, coordinate line readiness/tech transfer, create/update SOPs, define PM requirements and maintenance plans, ensure spares/training are in placeSupport quality investigationsDrive continuous improvement with Lean to improve OEE, scrap rates, uptime and cycle times Mentor/train Engineers and Technicians (no direct reports); structured troubleshooting/problem solving and Best Known Methods; develop quick-reference guides/checklist, where needed Promote safety and EHS and adhere to all Company policies, procedures and guidelines Your Profile Bachelor's degree in Engineering (Mechanical, Electrical, Chemical, Industrial/Manufacturing, Pharmaceutical or Materials) or equivalent4+ years in regulated manfuacturing Project management and CAPEX executionSix Sigma Green/Black Belt and/or PMPValidation and QMS: URS, FMEA, VMP, IQ/OQ/PQ/PV; author/review protocols/reports, managing deviations/CAPA; change controls Working knowledge of cGMP, ISO 9001, ISO 15378Knowledge and experience in leading new equipment/NPI validationsLean/CI; 5S, Kaizen, DMAIC, root cause (5-why, fishbone)Tools: SAP, MS Project, MS TEAMS, Solidworks and MinitabStrong skills in MS Office Ability to read, write and speak EnglishTeam player with upbeat approach Your Benefits Excellent healthcare benefits including medical, dental and visionShort and long term disability Tuition reimbursement Paid time offPet insurance Other supplemental benefits available upon election Please feel free to contact usYour Profile Bachelor's degree in Engineering (Mechanical, Electrical, Chemical, Industrial/Manufacturing, Pharmaceutical or Materials) or equivalent4+ years in regulated manfuacturing Project management and CAPEX executionSix Sigma Green/Black Belt and/or PMPValidation and QMS: URS, FMEA, VMP, IQ/OQ/PQ/PV; author/review protocols/reports, managing deviations/CAPA; change controls Working knowledge of cGMP, ISO 9001, ISO 15378Knowledge and experience in leading new equipment/NPI validationsLean/CI; 5S, Kaizen, DMAIC, root cause (5-why, fishbone)Tools: SAP, MS Project, MS TEAMS, Solidworks and MinitabStrong skills in MS Office Ability to read, write and speak EnglishTeam player with upbeat approach
About us Your Contribution Provide support to Production by visually inspecting sterilized glass vials throughout daily activities; identify and classify defectsPerform visual inspection and testing of incoming materials using statistical sampling techniques, precision measuring instrumentation and FT-IR to ensure conformancePerform laboratory tests including endotoxin, bioburden and sub visible particlePerform Environmental Monitoring in ISO level Clean Room including compressed air testingConduct inventory of laboratory supplies and communication needs for order placement(s)Collect WFI (Water For Injection) for testing using aseptic techniqueCommunicate non-conforming issues and interact effectively with proper contact(s)Demonstrate flexibility in providing coverage during instances of co-work vacation time and/or medical absence(s)Cross train in other areas and/or functions of the laboratory to support business needsComplete daily, weekly and monthly cleaning of applicable laboratory areasReview testing documents for completeness and accuracyMaintain all laboratory notebooks and equipment log booksWork on all assigned tasks, projects and daily tasksFollow all Company policies and proceduresParticipate in required trainings and meetings, when necessaryHelp promote and implement safety/EHS directives and maintain a clean and safe workspaceFollow cGMP and adhere to all ISO and safety guidelines and policies Your Profile High School Diploma or GED, requiredQuality Control and laboratory experience, preferredExperience working in a fast-paced manufacturing settingUnderstanding of cGMP and ISO, preferredBasic computer knowledge and skills including MS OfficeMulti-tasking abilitiesDetail oriented approach; ability to follow directions and instructionsPositive team approachEffective communication skillsAbility to read, write and speak English language Your Benefits Excellent healthcare benefits including medical, dental and visionShort and long term disability Tuition reimbursement Paid time offPet insurance Other supplemental benefits available upon election Please feel free to contact usYour Profile High School Diploma or GED, requiredQuality Control and laboratory experience, preferredExperience working in a fast-paced manufacturing settingUnderstanding of cGMP and ISO, preferredBasic computer knowledge and skills including MS OfficeMulti-tasking abilitiesDetail oriented approach; ability to follow directions and instructionsPositive team approachEffective communication skillsAbility to read, write and speak English language
About us Your Contribution Assist in planning, designing, fabricating and installing wiring and control systemsTackle bench-work activities to include, rebuilds, wiring, operational checks and upgradesWork in conjunction with Maintenance Technicians to repair mechanical, pneumatic, hydraulic systems, electrical/electronic systems Perform work by referencing and adhering to technical manuals, electrical schematics and wiring diagrams, shop drawings, data sheets, wiring drawings and other documented specificationsSupport facility systems including chillers, air handling, boilers, etc.Interface with Production, Engineering, Quality and Supply Chain contactsMonitor and perform seasonal electro-mechanical activities on equipment during non-standard work hoursDemonstrate flexibility in covering other shifts during instances of employee vacations or call-offs with the departmentPerform maintenance of site grounds, including snow removal, moderate gardening and weed controlParticipate in required trainings and meetingsHelp guide and train new hiresFollow Company policies, SOPs, GMP, ISO and safety protocolsMaintain a tidy and safe workspace Your Profile High School Diploma or GED, requiredTrade School and/or Vocational School Diploma, preferredElectro-mechanical experience (at least one year), strongly desired Sound technical abilities (troubleshooting electrical circuits, mechanical systems, pneumatics), along with facility systems Understanding of ISO and cGMP, preferred; ability to follow directions and instructionsBasic PC skillsAbility to read, write and speak English language Multi-tasking abilitiesDetail oriented approachUpbeat, team approachSolid communication skillsService oriented approach Your Benefits Excellent healthcare benefits including medical, dental and visionShort and long term disability Tuition reimbursement Paid time offPet insurance Other supplemental benefits available upon election Please feel free to contact usYour Profile High School Diploma or GED, requiredTrade School and/or Vocational School Diploma, preferredElectro-mechanical experience (at least one year), strongly desired Sound technical abilities (troubleshooting electrical circuits, mechanical systems, pneumatics), along with facility systems Understanding of ISO and cGMP, preferred; ability to follow directions and instructionsBasic PC skillsAbility to read, write and speak English language Multi-tasking abilitiesDetail oriented approachUpbeat, team approachSolid communication skillsService oriented approach
About us Your Contribution Ensure throughput and product qualityReview production KPI reports and electronic board for accuracy; control production order variances (hours/material/consumption)Review and manage re-inspection backlogs, quality issues and machine changes, along with handling and material issuesLead, instruct and motivate team employees on department deliverables and objectivesSupervise work performance, perform audits, provide control measures within the range of responsibility, and determine necessary improvement activitiesParticipate in the preparation and modification of job descriptions and the hiring processCreate planning documents and schedule/organize staffing to meet business needs based on the production schedule, vacations, call-offs, special needs, etc.Foster open communication with the Operations Manager, while reporting on all relevant data (production quantities, quality, accomplished order production, tool availability, maintenance tasks, etc.)Host daily shift meetings to provide daily instruction and staff allocationAssist in the development and implementation of training programs, in conjunction with the Department Training Coordinator, while continuously evaluating needs per positionPerform annual performance evaluations; document as requiredIssue disciplinary action for poor performance and/or misconduct, etc.Ensure clean workspaces on the Production floorMaintain the accuracy of employee time and attendance within the payroll systemLead and foster troubleshooting activities regarding potential issues on the Production line(s)Help promote and implement safety/EHS directives and maintain a clean and safe workspaceFollow cGMP and adhere to all ISO and safety guidelines and policies Your Profile High School Diploma or GED, requiredExperience in leading and directing the work of others in a fast paced manufacturing settingExperience in machine operation; glass manufacturing experience highly preferredUnderstanding of ISO and cGMP, preferredAbility to follow directions and instructionsAbility to read, write and speak English languageMulti-tasking abilitiesDetail oriented approachUpbeat, team approachRobust communication skills and openness to learn/develop Your Benefits Excellent healthcare benefits including medical, dental and visionShort and long term disability Tuition reimbursement Paid time offPet insurance Other supplemental benefits available upon election Please feel free to contact usYour Profile High School Diploma or GED, requiredExperience in leading and directing the work of others in a fast paced manufacturing settingExperience in machine operation; glass manufacturing experience highly preferredUnderstanding of ISO and cGMP, preferredAbility to follow directions and instructionsAbility to read, write and speak English languageMulti-tasking abilitiesDetail oriented approachUpbeat, team approachRobust communication skills and openness to learn/develop
About us Your Contribution Possess knowledge and capabilities to execute Maintenance/Facilities Technician (all levels) roles and responsibilitiesMonitor daily work orders and employee activitiesCoordinate with various department stakeholders on Maintenance actionsHelp minimize machine downtimeLead, coach and train Maintenance TechniciansProcure parts, materials and resources to increase machine uptime; impart expertise and techniques to others within the departmentEstablish shift schedules to meet business needs; manage employee schedulesActively lead and participate in projects/events to drive improvementsFill in for the Maintenance Manager, as neededHelp with achieving department deliverables and initiatives Participate in the interviewing/hiring processHost meetings accordinglyEnsure clean and safe workspacesMaintain attendance within the payroll systemFollow cGMP and adhere to all ISO and safety guidelines and policies Your Profile High School Diploma or GED, required / Vocational school degree, preferredMinimum (3) years of maintenance/facilities experience in leading and directing the work of others in a fast-paced manufacturing settingStrong mechanical aptitudeUnderstanding of ISO and cGMPAbility to foster and follow directions and instructionsAbility to read, write and speak English languageMulti-tasking abilitiesDetail oriented approachUpbeat, team approachService orientedRobust communication skills and openness to learn/developWork a fixes 8-hour shift schedule Monday to Friday, but some weekend/night work, as neededUp to 5% travel, if needed to satisfy business demand Your Benefits Excellent healthcare benefits including medical, dental and visionShort and long term disability Tuition reimbursement Paid time offPet insurance Other supplemental benefits available upon election Please feel free to contact us You can expect interesting tasks and challenging projects, as well as motivated and friendly teams in fields that influence our future.
About us Your Contribution Lead, coach, and motivate employees within respective area of responsibility, while providing direction to achieve department goals and objectivesAssist in developing department budget and investment plan(s) according to strategic goalsCultivate employee talent through training and coaching measures, while also conducting employee performance reviewsSupport the development and updating of Quality Assurance programs, policies, processes, procedures and controlsReview, analyze and report on quality discrepancies related to SCHOTT products, while developing disposition and corrective actions for product discrepanciesManage the review of batch records and avoid impacting shipment datesManage Department Training Coordinator activities and projectsManage document control activities to include, releasing, archiving, tracking and reporting of the document review process for controlled documentsLead and support the implementation of Systems and Compliance Improvements including site compliance, along with data integrity requirementsMeasure and analyze Quality System trendsOversee the internal audit function to ensure ongoing compliance to the Quality Management System (QMS)Maintain the Archive Room and document retention requirementsWrite and revise Standard Operating Procedures (SOPs) and provide training, as requiredManage the CAPA and Change-Control process to include, issuing, reviewing and approving stepsSupport all customer or registrar quality related audits and/or evaluationsUtilize quality tools, including Compliant-PRO, etc., for information, tracking and reporting purposes, as required by the Pharm Business UnitManage assigned CAPA(s) by performing root cause investigations, while defining resolution actions; implement preventive and corrective actions in a timely manner as a result of customer complaints or customer audit findingsHelp promote and implement safety/EHS directives and maintain a clean and safe workspaceAssure compliance with ISO certifications and cGMP, along with adherence to Company policies and procedures and Code of Conduct/safety guidelines Your Profile Bachelor’s Degree in Chemistry, Biology, Engineering or science related field, requiredMinimum three years of experience in Quality leadership roleSolid knowledge of ISO 9001, 14001, 15378, along with cGMP and ISOExposure to the glass forming industry and/or pharmaceutical industry, preferredThorough MS Office applications, SAP and electronic QMS systemsMulti-tasking abilitiesDecision makingDetail oriented approachForward/creative thinkingService orientedEffective communication skillsAbility to read, write and speak English language Your Benefits Excellent healthcare benefits including medical, dental and visionShort and long term disability Tuition reimbursement Paid time offPet insurance Other supplemental benefits available upon election Please feel free to contact usYour Profile Bachelor’s Degree in Chemistry, Biology, Engineering or science related field, requiredMinimum three years of experience in Quality leadership roleSolid knowledge of ISO 9001, 14001, 15378, along with cGMP and ISOExposure to the glass forming industry and/or pharmaceutical industry, preferredThorough MS Office applications, SAP and electronic QMS systemsMulti-tasking abilitiesDecision makingDetail oriented approachForward/creative thinkingService orientedEffective communication skillsAbility to read, write and speak English language
Dieser absolut wichtige Teil Ihrer Aufgabe und Ihrer Verantwortung darf gerne 50% Ihrer Tätigkeiten beanspruchenProzesskonforme Dokumentation und Reviews: Sie stellen die korrekte Dokumentation unserer Software-Entwicklungsprojekte und führen regelmäßige Reviews durch.Medizinproduktakten: Die Erstellung und Pflege von Akten gemäß der Medical Device Regulation (MDR) gehört zu Ihrem know howWeiterentwicklung des QM-Systems: Ihre aktive Mitarbeit bei der kontinuierlichen Verbesserung des Qualitätsmanagement-Systems im Bereich Software-Entwicklung ist gewünscht.Cybersecurity: Zusammen mit dem Cybersecurity Experten unterstützen Sie das Team bei Sicherheitsfragen und der Umsetzung von Cybersecurity-Maßnahmen.Usability- und Risikomanagement: Sie sind aktiv an der Durchführung von Usability- und Risikomanagementaktivitäten beteiligt.
Das Unternehmen bietet Raum für Menschen, die Verantwortung übernehmen möchten und Freude daran haben, an anspruchsvollen, zukunftsorientierten Technologien mitzuwirken Weiterentwicklung eines schlanken, risikobasierten Qualitätsmanagementsystems (ISO 13485, AI Act) Sicherstellung regulatorischer Anforderungen für aktive Medizinprodukte, sterile Produkte sowie Software as a Medical Device (SaMD) Vorbereitung, Koordination und Begleitung internationaler Zulassungs- und Registrierungsprozesse (EU/MDR, USA/FDA) inkl.
Wir entwickeln, fertigen und liefern unsere Premiumprodukte an die wichtigsten Hersteller in aller Welt in den Branchen Medical, Test&Measurement, Military, Robotics und wachsen seit 30 Jahren sehr dynamisch. Quality is key in unserem globalen, innovativen und stetig weiter expandierenden Unternehmen.
Das Unternehmen bietet Raum für Menschen, die Verantwortung übernehmen möchten und Freude daran haben, an anspruchsvollen, zukunftsorientierten Technologien mitzuwirken Weiterentwicklung eines schlanken, risikobasierten Qualitätsmanagementsystems (ISO 13485, AI Act) Sicherstellung regulatorischer Anforderungen für aktive Medizinprodukte, sterile Produkte sowie Software as a Medical Device (SaMD) Vorbereitung, Koordination und Begleitung internationaler Zulassungs- und Registrierungsprozesse (EU/MDR, USA/FDA) inkl.
We know: motivated and committed employees are the precondition for the success of our company. Further training and education; Free Parking; Medical, Dental and Vision coverage; Talent development; Team Events; paid vacation days, holidays and sick time Please feel free to contact us You can expect interesting tasks and challenging projects, as well as motivated and friendly teams in fields that influence our future.
Talent development; Free Parking; Further training and education; Medical, Dental and Vision coverage; Multiple career opportunities; Team Events; paid vacation days, holidays and sick time Please feel free to contact us You can expect interesting tasks and challenging projects, as well as motivated and friendly teams in fields that influence our future.
PSURs).Du unterstützt klinische Strategien in Zulassungs- und Entwicklungsprojekten.Du bist in Risikomanagementprozesse eingebunden.Du gestaltest aktiv mit: Vorlagen, SOPs und Arbeitsanweisungen entwickelst Du eigenverantwortlich weiter.Du kommunizierst mit Behörden, Fachkreisen und internationalen Partnern.Ausbildung/ Studium: Du bringst ein abgeschlossenes Masterstudium in Medizin, Naturwissenschaften, Medizintechnik oder einem vergleichbaren Bereich mit.Fachwissen:Erste Erfahrung mit wissenschaftlichem Arbeiten, idealerweise mit Fokus auf Medical Writing, klinische Datenanalyse oder klinische Bewertung.Kenntnisse relevanter Regularien (MDR, ISO 14155, MDCG) sind ein Plus.Idealerweise bringst Du Produktkenntnisse in der Endoprothetik mit.Soft-Skills: Du arbeitest strukturiert, bist analytisch starkDu bist kommunikationsstark und ein echter TeamplayerSprachkenntnisse: Du sprichst und schreibst Deutsch und Englisch mindestens auf C1-Niveau.Unsere Stellenausschreibung gibt Dir einen Einblick in die Anforderungen der Position.
About us Our Business Unit Lighting and Imaging offers challenging lighting and image transmission solutions for applications in the markets of automotive, aviation, medical devices, as well as industrial and safety engineering. With production units in Europe, North-America and the worldwide SCHOTT sales organization Lighting and Imaging is a leading supplier for fiber optic components.
Ability to identify issues, assign tasks and effectively communicate with both superiors, subordinates and customers to achieve agreed goals and objectives related to machine acceptance. Benefits Medical, Dental, Vision insurance offered at 30 days of employment Generous Educational Reimbursement program Company sponsored Life and Disability Insurance Paid Time Off Ten (10) Paid Holidays per year 401K with Company Match Location: Waukesha ǀ Wisconsin ǀ USA
Ability to identify issues, assign tasks and effectively communicate with both superiors, subordinates and customers to achieve agreed goals and objectives related to machine acceptance. Benefits Medical, Dental, Vision insurance offered at 30 days of employment Generous Educational Reimbursement program Company sponsored Life and Disability Insurance Paid Time Off Ten (10) Paid Holidays per year 401K with Company Match Location: Waukesha ǀ Wisconsin ǀ USA
For our esteemed client in the pharmaceutical industry, we are looking for a Supplier Quality Engineer Packaging (m/f/d) based in Bad Homburg. Become part of a globally leading company in medical devices and pharmaceuticals and take responsibility for qualifying packaging suppliers and driving the global harmonization of packaging standards.
Working knowledge of a broad range of packaging materials, packaging equipment and packaging lines commonly found within the Food, Beverage or consumer industries Experience with development of large packaging project proposals Equivalent combination of education and experience will be considered Benefits Medical, Dental, Vision insurance offered at 30 days of employment Generous Educational Reimbursement program Company sponsored Life and Disability Insurance Paid Time Off Ten (10) Paid Holidays per year 401K with Company Match Location: Waukesha ǀ Wisconsin ǀ USA
Working knowledge of a broad range of packaging materials, packaging equipment and packaging lines commonly found within the Food, Beverage or consumer industries Experience with development of large packaging project proposals Equivalent combination of education and experience will be considered Benefits Medical, Dental, Vision insurance offered at 30 days of employment Generous Educational Reimbursement program Company sponsored Life and Disability Insurance Paid Time Off Ten (10) Paid Holidays per year 401K with Company Match Location: Waukesha ǀ Wisconsin ǀ USA
Fonterra is a co-operative owned by around 9,000 New Zealand dairy farmers. Fonterra’s focus is on Active Living, Medical Nutrition and Infant Dairy and with this variety of products Fonterra reaches markets in China, Japan, Indonesia, America, Europe and more.
This includes the ability to work unsupervised, under pressure and meet deadlines • Creative with strong commitment to quality and excellence, and a continuous improvement mindset • Communication and time-management skills • Strong analytical skills and efficient problem solving • You are educated on master degree level in IT Security, Computer Science or equivalent, fluent in English WHAT IS THE PLUS POINT (S): • Certifications such as SEC545 (SANS), CCSP(ISC2), CISSP, CCSK(CSA), Microsoft Certified Azure Security or similar • DevSecOps experience related to application deployments on multi cloud • Strong experience on cloud platforms such as Google, Amazon and Azure WHAT YOU WILL GET FROM US: • Great team of IT professionals with global working exposure • On-going professional and technical training and certifications • Global internal job opportunities available within DPDHL • A multicultural environment • Meal Card and Flexible Benefits – customized according to individual needs • Choose any day for your vacation from earned public holiday (Saturday and ad hoc) • Smart casual dress code • Company Outpatient Medical • Home office possibilities Sounds good? Start your application now! Location: GER / PRG
Are you able to take responsibility for the development of novel medical devices? Do you see your strength in creating a trusting and open cooperation with external partners? And do you want to join a successful company in rapid growth?