Foamtec International Quality Control and New Product Coordinator in Woodway, Texas
Quality Control/New Product Development CoordinatorOverviewQC/NPD Document Controller has primary responsibility for record-keeping and document management for Foamtecs regulated businesses, including Medical Device, Pharmaceutical, Life Sciences and Microelectronics. The Document Controller will interface with all levels of sales and operations, both within the US and Thailand, and will follow-up on and report on project status. The qualified candidate will have prior experience with documentation and project management within a life science company that maintains an ISO13585, cGMP quality system.Job ResponsibilitiesMaintain files of Finished product specifications, coordinate approvals with sales and customersOrganize distribution and process procedures to maintain compliance to ISO 90001, ISO 13485, and cGMPProvide Certificates of Compliance for custom products, and technical documents such as technical data sheets as requested by Sales Team and customersSubmit cost and sample requests to counterparts in Thailand, and follow up on project statusLead a weekly status meeting with Thailand NPD team and publish notes. Follow up on actions required from Thailand NPD and sales.Maintain samples and reports of all new product developmentInteract with regulatory agencies such as US FDA for certification, approvals/certificates, and document from those agencies.Review and report that the company is within compliance to ship and store hazardous materials.Maintain MRB (Material Review Board) area. Actively work to correct product issues and release products.Identify and resolve discrepancies in documentation and labeling.Create and control new documentation as needed.Prepare internal documentation for submittal to inspectors and auditors from regulatory agencies, customers, and certifying agency auditors.Other projects as assigned involving QC and New Product DevelopmentKnowledge, Skills, and Abilities RequiredHigh level of organization skills requiredAbility to work independently in a fast paced, high pressure environment is requiredAdvanced knowledge of Microsoft Excel, Word and OutlookAdvanced communication and problem-solving skillsQualifications4-year college degree in science5+ years working experience in regulatory and/or product development/product manufacturing.Working knowledge of US FDA medical device for manufacturing (cGMP and FDA 21 CFR 820) and packaging.Familiarity with ISO 13485 and ISO 9001.