solutions consultant.

job summary: Rapidly growing Medical Device company in the Columbia, SC area is currently in search of a Lead Manufacturing Engineer that has experience with overseeing and implementing new highly automated equipment lines. Lead Manufacturing Engineer should also have experience working with suppliers on tooling validations, developing and leading projects to improve process monitoring, quality and reduce costs. The Lead Manufacturing Engineer will also work within final assembly manufacturing environment(s) and drive early-stage process development and manufacturing optimization to ensure products meet design intent.   location: Lexington, South Carolina job type: Permanent salary: $115,000 - 145,000 per year work hours: 8am to 4pm education: Bachelors   responsibilities: Work within final assembly manufacturing environment(s) and drive early-stage process development and manufacturing optimization to ensure products meet design intent.Work with and manage external suppliers, conduct DFM reviews, and go onsite as needed.Partners with Quality and Regulatory, R&D, and operations to ensure compliance of the manufacturing processes, provide support, for regulatory filings, and ensure the robustness of the process and raw materials. Develop and lead projects to improve process monitoring, quality and reduce costs. Conduct root cause failure analysis and corrective action. Establish sampling and Quality plansParticipate and/or lead risk management activities including product and process FMEA. Support reliability engineering activities. Participate and/or lead validation activities for design, process, or products. Development and qualification of test methods for verifications and validations. Write and execute study protocols, technical reports, manufacturing work instructions (MWI), validations, reports, batch records, design control and other documents as required. Develop and implement manufacturing processes and measurement methods to meet tight tolerance manufacturing requirements and manufacturing scale up.Lead development of fixtures, equipment, and automation.Interface with contract manufacturers and suppliers.Process evaluations and lead process optimization initiatives utilizing tools such as SPC, DOE, PFMEA, and MSA. Evaluation and continuous improvement of process capabilities. Requirements: A BS in Mechanical, Manufacturing, or related Engineering field is required, MS preferred.Minimum of 4 years of medical device design and development experience, preferably on class II or III medical devices. Experience in high volume product design ( >10 million units per year), a strong plusA Track record of generating novel ideas, and out of the box thinker and a true entrepreneurial mind set, a strong plus. Proven ability to solve problems and improve manufacturing processes that use high precision mechanical components. Experience in the scale-up of high volume consumable medical devices. strong working knowledge and experience in manufacturing processes, process development and validations for finished medical devices. Knowledge of laser welding, heat staking, engraving and plastics processing equipment a plus.Successful implementation and use of statistical based quality improvement tools such as design of experiments, Statistical Process Control and GAGE R&R. Experience in equipment and automation developmentKnowledge of medical regulations; ISO13485 and CGMP procedures. Project leadership in multi-disciplined projects. Experienced in quality system requirements for the medical device industry. Proven ability to motivate and lead others, often without direct control, such as suppliers. Self-motivated, team-oriented individual who collaborates and communicates effectively with local and international team members in a cross-functional, multi-cultural, interdisciplinary environment. Comfortable working in an extremely dynamic and fast paced environment, and able to meet aggressive development milestones. #LI-AS1   qualifications: Experience level: ExperiencedMinimum 5 years of experienceEducation: Bachelors (required)  skills: Six SigmaManufacturingLeanProcess ImprovementManufacturingManufacturing Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status. For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.

job summary: Quality Technician needed at leading manufacturing company located in West Coumbia, SC. This is a temp to perm opening. APPLY NOW! Requirements: Experience with Microsoft Office, especially Excel, Word, and PowerPoint *At least 3-5 years in a quality related role. Certificates, Licenses, Registrations: *ASQ certification as CQT, CQA, CQPA or CSSGB is desired  location: West Columbia, South Carolina job type: Contract salary: $20.00 - 23.50 per hour work hours: 8am to 4pm education: Associates   responsibilities: *Audits processes, tests and inspects products and/or develops, compiles and evaluates statistical data to determine and maintain quality and reliability of products. *Working from engineering drawings, specifications, schematics, diagrams, written descriptions, layouts or defined plans to perform complex engineering testing, checkout, First Article Inspection, root cause analysis, internal corrective actions and supplier correction actions. *Interprets engineering drawings, schematic diagrams or formulas and confers with management or engineering staff to determine quality and reliability standards. *Selects processes to be audited from primarily the manufacturing areas and checks for a variety of features, including ESD (electro-static discharge) and handling practices, documentation, training and process integrity. *Selects products for audits at specified stages in the production or post-production process, and tests products for variety of qualities such as dimensions, performance and mechanical, electrical or cosmetic characteristics. *Records audit data, applying statistical quality control procedures. *Evaluates data and writes reports to validate or indicate deviations from existing standards. *Recommends modifications of existing quality or production standards, programs or reports to achieve optimum quality within limits of equipment capability. *Prepares graphs or charts of data or enters data into computer for analysis. *Download quality information from quality system to be used for QA reports. *Analyzes engineering test results and implements process changes to resolve problems ,Performs out of box audits (OBA) as required, Provides factory support to identify and resolve issues associated with purchased parts, materials and manufacturing, May be required to perform receiving inspection *Assist quality engineer in creating product audit procedures, quality management procedures, PFMEA, and Control Plans.   qualifications: Experience level: ExperiencedMinimum 3 years of experienceEducation: Associates  skills: QualityProcess ImprovementSix SigmaManufacturingElectricalElectro-mechanicalMechanical Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status. For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.

job summary: Testing Technician needed at leading manufacturing company located in West Coumbia, SC. This is a temp to perm opening. APPLY NOW! Shift is 12 hours 7:00 a.m.-7:00 p.m. 3 days week 1, 4 days week 2. Requirements: Minimum of an Associates degree, Military technical training, or equivalent experience and training, 3-4 years experience. Automation in production and is subject to ISO 13485  location: West Columbia, South Carolina job type: Contract salary: $17.50 - 25.50 per hour work hours: 8am to 4pm education: Associates   responsibilities: Develops, maintains and improves all test and burn-in processes within area of responsibility.Periodically reviews all process specifications to determine if it accurately reflect the process requirements and test techniques. Updates the specifications as required.Ensures that test and burn-in processes are within all safety specifications.Consistently reviews quality yields and develops corrective actions to eliminate any yield detractors, further improves the process reliability.Assists with the fabrication and development of new equipment, fixtures and test programs (where applicable).Ensures that effective preventive maintenance, diagnostics, and daily measurement schedules are in place for each test and burn-in process.Coordinates preventive maintenance activities. Ensures that scheduled preventive maintenance activities are completed according to the specified schedule.Assists engineering and the development labs with all new product introduction and development.Coordinates and monitors all FIMPA or product off-load activities for assigned test and burn-in processes.Ensures that each test and burn-in process has a training/certification package for both manufacturing and maintenance. Facilitates the completion of these training/certification packages with the appropriate engineer(s) and the Resource Development Department.Partners with Industrial Engineering on all equipment moves or line re-arrangements as required.Drives recovery actions/repair of any test or burn-in process that is down. Coordinates recovery/repair activities with the respective maintenance, technicians, engineers, suppliers or maintenance spare parts analyzers whose area of competence is necessary to get the process back in working order.Assists test engineers in development of disaster recovery plans for each test and burn-in process within the area of responsibility.Follows Engineering test processes.Ability to perform high-level repair, format and "build" software per unit configuration and connect hardware (cables) between multiple units.Configures/flashes firmware on Sub-assemblies and connects Ethernet connections between unit(s).Understands the basics of Disk Arrays and set up for Disk Arrays.Troubleshoots/debugs at multiple system levels. Ability to determine workmanship errors and drive back through quality.Performs module verification.Be able to troubleshoot wiring of units using schematic diagram and assembly process.First line support for workstation and line issues.Log and fail defects of units and parts that are defective and address trending failures.   qualifications: Experience level: ExperiencedMinimum 3 years of experienceEducation: Associates  skills: ElectronicsProductionMaintenanceManufacturingTestingAutomation TesterDiagnosticsISO 13485Process Improvement Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status. For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.