[{"country_short": "USA", "city": "Clearwater Site", "description": "Title: Quality Engineer\nLocation: United States-Florida-Clearwater Site\n\nSummary:\nThe role of Quality Engineer Insertion Devices is integral to the on-going compliance of the inserter manufacturing processes. The Quality Engineer is involved in all stages of the product life cycle including:\n\n\u00b7 New Product Support:Works with project teams to ensure the product is transferred into manufacturing right the first time and validations are conducted in accordance with requirements.\n\u00b7 Manufacturing support: Leads efforts in conjunction with manufacturing and engineering to develop plans for continual improvement of product and process quality. Ensures that decisions are made based on sound Quality principles and regulatory guidelines. Supports/leads investigations and corrective action efforts. Promotes use of statistical analysis for determination of improvements, and provides analyses to support risk mitigation.\n\u00b7 Post-launch maintenance: Evaluates complaint trends and drives improvements. Investigates individual complaints as needed.\n\nManufacturing Support\n\u00b7 Supports manufacturing in improvement of processes, resolution of issues, maintenance/ improvement of quality system.\n\u00b7 Uses Lean/six sigma tools to identify areas of improvement, specifically related to process controls.\n\u00b7 Guides engineering/manufacturing personnel in establishment of appropriate qualification, validation criteria. \n\u00b7 Evaluate proposed changes for design control requirements.\n\u00b7 Independently leads failure investigations, using root cause analysis tools, and proposing/implementing systemic corrective actions. Identifies areas of systemic weakness, and leads initiatives to implement corrective action.\n\nAnalyzes data\n\u00b7 Uses relevant statistical tools to analyze data for proactive improvements.\n\u00b7 Uses relevant statistical tools for leading problem solving activities.\n\u00b7 Provides routine analysis of performance indicators. Presents this information to management, supervisors, and manufacturing operators. Leads initiatives to improve performance.\n\nCore team member for new product development\n\u00b7 Key participant in the design transfer process. Guides project team in development of validations of the manufacturing process and quality plans for the integration into manufacturing. \n\u00b7 Evaluates current Quality System, and determines how new products will fit within system. Determines if any changes are required.\n\u00b7 Leads teams to develop PFMEA for new processes and process changes. Focus team on implementing capable processes, process controls, and error-proofing measures.\n\u00b7 Develops/updates Risk Management files.\n\u00b7 Support development of verification and validation strategies. Guides team on proper components of IQ/OQ/PQ/PV activities.\n\nBausch  Lomb is one of the best-known and most respected healthcare brands in the world, offering the widest and finest range of eye health products including contact lenses and lens care products, pharmaceuticals, intraocular lenses and other eye surgery products. The company is solely dedicated to protecting and enhancing the gift of sight for millions of people around the world \u2013 from the moment of birth through every phase of life. Our mission is simple yet powerful: Helping you see better to live better.\n\nEducation:  \nFour-year college degree (BA/BS) in fields such as life or physical sciences, or engineering. \n\nExperience:\n2-4 years Quality experience. Experience with medical devices preferred. Strong verbal and written communication skills, ability to manage multiple priorities. Working knowledge of 21 CFR 820, ISO 13485, ISO 9001, Quality tools, and problem solving tools, statistical analysis. \n\nSpecial Skills:\nQuality Tools - Quality Planning, Costs, Assessment, Basic /or Advance Statistical Techniques, Tech Writing, Metrology & Calibration, Inspection & Testing, Sampling Principles & AQL, TQM, Six Sigma\n\nProblem Solving Tools - Process Mapping, Histograms, FMEA, Risk Assessment, Cause & Effect Diagrams, PCDA, Pareto Analysis\n\nComputer & Information Technology Skills \u2013 Windows, Word, Excel, Power Point, Project, Visio, statistical software (i.e. Minitab).\n\nSpecialized Training:ASQ Certified Quality Engineer or equivalent preferred.Job: Quality", "date_new": "2012-02-11 00:17:02", "url": "http://bausch.jobs/xml/26469742/job", "country": "United States", "company": "Bausch + Lomb", "title": "Quality Engineer", "reqid": "00007503", "state": "Florida", "state_short": "FL", "location": "Clearwater Site, FL", "uid": 26469742}, {"country_short": "USA", "city": "Clearwater Site", "description": "Title: Sr. Mfg Process Engineer\nLocation: United States-Florida-Clearwater Site\nPosition Summary\n\nThe Process Engineer is responsible for developing, documenting, validating, maintaining and improving manufacturing processes, related to the manufacture, inspection and packaging of lathed intraocular lenses. Specific tasks to include: new technology and process improvements for existing manufacturing processes, lathe and milling competency, optics knowledge, leadership support for increasing product quality and process productivity enhancements, support for new process transfer into production and other projects which may be assigned by the Engineering Manager. Knowledge of cGMPs for medical devices a plus, strong technical writing skills.\n\nSpecific Job Duties\n* Provide leadership and support for increasing product quality and productivity and reducing product cost. Conduct Engineering studies, DOE\u2019s and process/equipment validations including preparing protocols, supporting execution of protocols and summarizing/analyzing results. Support development of operating procedures and training of manufacturing technicians. \n* Provide manufacturing process engineering support for the transfer of new products into manufacturing, as managed by the Research and Development Group and Plant Engineering. \n* Respond to requests for engineering support to technical / operational issues in the production process are quickly and effectively resolved. \n* Manage the design and development of new equipment, tooling, or fixtures to be used in the manufacture, inspection, sterilization, or packaging of intraocular lenses or related ophthalmic devices. \n* Technical interface with component vendors to communicate part requirements, to resolve technical issues, and to develop long term reliability of vendor supplied parts.\nBausch  Lomb is one of the best-known and most respected healthcare brands in the world, offering the widest and finest range of eye health products including contact lenses and lens care products, pharmaceuticals, intraocular lenses and other eye surgery products. The company is solely dedicated to protecting and enhancing the gift of sight for millions of people around the world \u2013 from the moment of birth through every phase of life. Our mission is simple yet powerful: Helping you see better to live better.\n\nEducation:  Bachelors Degree in Engineering, Mechanical Engineering or equivalent\n\nExperience: 8 years related experience with two years of experience in medium to high volume manufacturing industry with experience in the medical device field preferred. Lathing and Milling competency experience and/or precision machining experience preferred.\n\nSpecial Skills: Must have clearly demonstrated hands-on problem solving skills, Engineering Design skills and Project Management skills. Good written communication skills with above average verbal communication skills. Solidworks CAD skills and CNC programming are a plus.\n\nSpecialized Training: Project Management, Knowledge of Statistical analysis techniques, DOE, Six Sigma/Lean Manufacturing, working knowledge of cGMP, ISO 9000 & 13485, ergonomic manual assembly workstation design, process flow, material handling, assembly fixture design. Six Sigma Green/Black Belt a plus.Job: Engineering Services", "date_new": "2012-01-25 08:04:15", "url": "http://bausch.jobs/xml/26097089/job", "country": "United States", "company": "Bausch + Lomb", "title": "Sr. Mfg Process Engineer", "reqid": "00007449", "state": "Florida", "state_short": "FL", "location": "Clearwater Site, FL", "uid": 26097089}]