suddl 发表于 10-1-2013 09:57 
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Job Openings as at 20 December 2012 ProductLifecycle Engineer Main Responsibilities: Product LifecycleManagement · Establishing appropriate master data settingsto facilitate product ramp-up or phase-out strategies · Collaborate with local and global teams toensure that product lifecycle strategies are implemented properly usingmaterial master data in the SAP system. · Ensure alignment of Material master andProduct settings in Factory works and Enovia. · Enhance/ Develop local procedures tomanage Product Lifecycle and Material master management process. Manufacturing Master Data and Change management · Work closely with Quality/ Engineering/Supply chain to ensure accuracy of relevant information on Materials/ BOM andRoutings for new products/ materials. · Determining correct material master data fornew materials, products and Bill of Materials. · Act as a focal point to drive Master dataalignment across various systems including Factory works, SAP, Indysoft andEnovia. · Support configuration activities related toproduct or process changes, ECR, ECO, MCO, new product. Data Process Governance · Create and maintain localprocedures for creating and maintaining high quality data. · Develop and maintain datamaintenance procedures at the local site, including developing tools andtemplates to help others adhere to the standards with the local organization · Defining and overseeing the datacollection process, including adherence to local quality system requirementsfor configuration/engineering change control. · Collaborating with the MasterData Governance to ensure full knowledge of and compliance to Corporate dataquality standards · Analyze and resolve data problemsthat may be causing downstream transactional issues · Measuring and reporting on localdata quality · Lead and participate to projectrelated to configuration and data management Requirements: · University Degree in IndustrialEngineering (preferred), Electrical Engineering, Information Systems, orComputer Science · Minimum of 3-5 years’ experiencein Manufacturing/ Planning and Execution used in Manufacturing environment withgood understanding of processes, materials and flows. · Preferably in Medical/ Pharmacontrolled environment. · Hands-on work experience with invarious IT systems/ applications used in Manufacturing environment. · Ability to learn the manufacturing processes/Bill of Materials/ Material requirements and to develop associated workflows. · Experience in managing changecontrol of such systems · Exceptional analytical andproblem solving skills · Experience with regulatorydocumentation and procedures QualitySystems Specialist Main Responsibilities: Responsibility Compliance of Quality System · Train QualitySystem users on the QMS processes and governance · Be the focus pointfor all questions related to QMS · Liaise with theentities connected to Quality System for maintaining the compliance level · Lead theharmonization of QMS to BU / corporate requirement · Involved in theQuality System Audit by external Notified Body and Agencies. · Perform internalaudit on QMS processes and provide support to the organization to improve theeffectiveness and efficiency of QMS processes. Deploy and MaintainQuality Metrics · Designorganization Quality Metrics for insuring a good monitoring of QMS efficiency · Maintain QualityMetrics data · CommunicateQuality Metrics to the Quality Management System Quality System ChangeManagement Process · Ensure that allQMS change are properly captured, reviewed, deployed and documented · Liaise withRegulatory Affairs for communicating the necessary change notification · Be the owner forthe standards surveillance. Trigger the applicable standards change in theorganization QMS Support / Coordinatethe Internal Audit, CAPA and Deviation Processes · Own & supportthe internal audit plan realization · Train and supportend users on QMS processes · Support & leadthe good CAPA process execution and escalate deviation to Quality management asrequired Requirements: · University Degree or Master or equivalentexperience. · Have a quality certification or demonstrateequivalent experience in the Medical Device or Pharmaceutical industry. · Minimum 2-3 years of experience inproject/team management on medium scope or background in product or processdevelopment projects. · Experience in the field of Pharmaceutical orMedical Device Industry and Quality Management System is an asset · Desktop applications, analytical tools,presentations, document management · Strong communication skills to participate inmulticultural and multi-departmental teams, and to lead a local technical team. · Good communication skills with people fromall levels in the organization. · Able to solve technical problems, autonomousand decision making abilities, requires minimal supervision · Coaching skills to act as a local technologymentor.
QAEngineer Main Responsibilities: · Assurethat processes comply with specifications, Quality Systems Regulations and ISOstandards. · Documentthat processes complies, with a high confidence level, the tolerances stated onthe product specification and drawings. · Establishmechanism to evaluate, measure, monitor and/or quality in our products. · Evaluateproduct/ material discrepancies. (PRB/MRB) on time, and implement correctiveactions accordant. · Workon new product transfers and actively participate in the qualifications andvalidations of product/ equipment and processes. · Providecheck and balance to manufacturing/system changes submitted by ManufacturingEngineers. · Workon special projects assigned by Supervisor/ Manager. · Supportmanufacturing activities by also participating on production meetings. · Updatemanufacturing processes in order to reflect quality concepts and specificationrequirements. · Applystatistical tools in order to assure that processes comply with thespecifications. · Ensurecompliance to audit findings in a timely manner. · Coordinatequalification and validation activities for all product and technologytransfers. · Participateon internal quality audits by reading and understanding the audit plan, checklist, and performing initial meetings with auditor. Participate in thegeneration of the written report of findings and in the wrap-up responses toassure corrective actions are implemented. · Evaluate/approve engineering change requests/ orders. · Conductfailure investigations in order to initiate, stimulate, and assign correctiveaction. Issue written reports and update, accordingly. Requirements: · Degreein Engineering. · Minimum3 years of experience in Engineering related to manufacturing of small electro/mechanical devices preferably in a quality assurance or test related capacity. · Goodcommunication and interpersonal skills with abilities to articulate ideasclearly and concisely to people of all levels. SeniorManufacturing Engineer Main Responsibilities: · Leading a team of Manufacturing Engineers and Technicians. · Responsible for the support of Manufacturing Operations, improving theoperational standards, contribution in yield improvement and processcapability/performance. · To lead and /or to participate in development,training, qualification and validation activities for product or technologytransfers. · Monitors and improves goals and metrics established for company andarea of responsibility. · To lead activities of Design for Manufacturability (DFM) andreliability. · Ensurescompliance with company policies, programs, procedures, regarding to government and regulatory agenciesregulations (e.g. ISO, FDA, OSHA). Ensure timely response to audit findings. · Works withthe Manufacturing and Supply Chain teams to apply principles, concepts andtools for capacity projects and LeanSigma initiatives. · Works andimplements special improvement projects as assigned by Direct Supervisor. Requirements: · Minimum 5years’ experience in Manufacturing Environment preferably in medical orelectronic devices including supervisory of Engineering team experience. · Experience inLean Sigma Methodology and Continuous Improvements Programs. · Excellent written reporting skills. · Possessstrong knowledge and experience in the FDA regulated work environment. · Experience inproject/team management or background in product/process development andproduct transfers projects. · UniversityDegree in Engineering or related discipline. ManufacturingEngineer Main Responsibilities: · Responsible for the support of Manufacturing Operations,maintaining or improving the specified operational standards. · Toprovide technical support to production personnel and manufacturing lines. · Todevelop, update and revise manufacturing documentation following standards,internal policies and regulations established by regulatory agencies. · To identify need, develop and provide adequate toolingand equipment to ease device manufacturability. · Revises proposals for new product specifications orcurrent specification modifications established by design documentation. · To initiate, evaluate, approve and implement EngineeringChange Order (ECR/ECO). · To analyze and to determine conformance of materials andassemblies. · Tolead and / or to participate in development,training, qualification and validation activities for product or technology transfers. · Totrain production personnel, and other engineers/technicians. · Monitors and improves goals and metrics established forcompany and area of responsibility. · Ensurescompliance with company policies, programs, procedures, regarding to government and regulatory agenciesregulations (e.g. ISO, FDA, OSHA). Ensure timely response to audit findings. · Workswith the Manufacturing and Supply Chain teams to apply principles, concepts andtools for capacity projects and LeanSigma initiatives. · Worksand implements special projects as assigned by Direct Supervisor. Requirements: · UniversityDegree in Engineering or related discipline. · Minimum3 years’ experience in Manufacturing Environment preferably in medical orelectronic devices. · Experiencein Lean Sigma Methodology and Continuous Improvements Programs. · Good written reporting skills. · Effectivecommunication skills.
Technician(12 Hour Shift) Main Responsibilities: · SupportsQualification/Validation for product/process according to schedule and followup production until pass off requirement met. · Supportsprocess improvement with IQ/OQ/PQ until pass off requirement met. · Supports/participates to Development activities. · Collaborateswith Transfer engineer and operation to evaluate, install, characterize,qualify and validate product/process/line in assigned scope of processes. · Collaborateswith Transfer engineer and operation to evaluate, characterize, qualify andvalidate major manufacturing and product improvements within performanceobjectives · Followsand coordinates IQ/OQ/PQ activities on the lines. · Trainsoperators and technical support of Implantable Device within IQ/OQ/PQactivities. · SupportsImplantable Devices tasks (technical support, non-conformity management,continuous improvements · SupportsOperation Excellence Initiatives Requirements: · Diploma/ ITC / NTC in Engineering or equivalent · Minimum 2 - 5 years relevant experience inequipment installation and maintenance in a manufacturing environment · Good knowledge of mechanical, electrical,electronics, pneumatic and PLC · Experience in the application of theprotocols of validation and/or tests of validation produced. · Experiment in a medium of production,maintenance or breakdown service managed by a quality system · Knowledge of Lean Manufacturing Software(office automation) · Familiar with MS Excel · Strongcommunication skills to participate in multicultural and multi-departmentalteams, and to lead a local technical team. · Ableto solve technical, logistic and human conflicts and problems. · Coachingskills to act as a local technology mentor. | 
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