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Participate in regulatory audits, FDA, ISO, UL, ETL etc. Ability to work with CAD data management software i.e. Solidworks PDM. AutoCAD, Creo a plus) The Mechanical Engineer is responsible for the design and development of mechanical components & assemblies, and reliability analysis on materials developed for medical devices.
Full-timeExpandApply NowActive JobUpdated 15 days ago - UpvoteDownvoteShare Job
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Ensures IT system operations, processes and management controls adhere to all applicable laws and regulations, including FDA Quality System requirements, ISO requirements and Sarbanes-Oxley internal controls over financial reporting.
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Manages the QMS for all sites and 3rd party registrations. Subject matter expert in ISO, IATF, and core quality tools. Reporting to the Chief Operating Officer as part of the Senior Leadership Team, the Director of Quality will develop, implement, and evaluate the quality management system utilizing expertise in operational excellence.
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General Responsible for compliance of Quality System regarding ISO Standard 13485 alignment with Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP), FDA and other applicable requirements, laws, and standards.
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Aseptic technique and knowledge of FDA BAM, ISO, CMMEF compendia methods. Aseptic technique and knowledge of FDA BAM, ISO, CMMEF compendia methods. Preference for FDA BAM testing method verification, challenge studies, shelf life studies and similar experience.
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Train new operators in the areas of Machine operation, Safety, Productivity, Quality, ISO procedures. Machine Operator- Packaging 3rd Shift. Operator must be able to manage multiple equipment modules simultaneously (i.e. fillers, cappers, cartoners, case packer.
Full-timeExpandApply NowActive JobUpdated 14 days ago - UpvoteDownvoteShare Job
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We need innovative doers to further our mission of becoming the sole digital layer for Utilities, Heavy Equipment Dealers, Manufacturers, and Construction to improve compliance (OSHA, ISO), productivity, recordable injury rates, and scrap and containment costs, by delivering instructional content to, and simultaneously extracting rich, contextual data from, frontline workers and supervisors.
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Understanding of medical device regulations and standards (e.g., FDA, ISO). Maintain a strong understanding of cost-optimization principles for packaging design. Experience with packaging materials, testing methodologies, and cost-analysis is preferred.
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Reports on QMS performance to top management identifying any needs for improvement. Ensures QMS processes are established , implemented, and properly maintained , including the oversight and control of all documents and data related to the requirements of the QMS system.
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Our state-of-the-art depots are strategically located near major manufacturing and transportation hubs to provide our clients with a quick and consistent turnaround on all their Tank and ISO Tank Container services needs.
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Understanding and knowledge of the ISO/OSI model at L1-L2 levels, as well as IPv6, TCP, and UDP protocols. Understanding and knowledge of the ISO/OSI model at L1-L2 levels, as well as IPv6, TCP, and UDP protocols.
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The Sr. Quality Engineer will be primarily focused on supporting new product development as well as supporting general sustaining activities while maintaining the effectiveness of the overall QMS. This position will support new product development and sustaining activities related to Vapotherm’s complete product portfolio with focus on both hardware and disposable products.
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As the job market remains highly competitive, we have seen a surge in "rage applying." This is when candidates apply to multiple jobs, often without considering whether they are truly interested in the role. Rage applying goes hand-in-hand with quiet quitting. Often, employees want to entertain the thoughts and feelings of leaving their job, but they aren't necessarily serious about leaving yet. Meanwhile, other employees engaging in this trend are actually trying to find a better role. As a recruiter, it can be hard to identify who are the real applicants in a sea full of quiet quitters, but understanding rage applying and identifying red flags will certainly help.
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In today's competitive job market, writing quality job ads is critical for attracting top talent to your organization. While networking and candidate referrals are prime real estate for finding qualified candidates, nothing beats the tried-and-true method of writing an extraordinary job ad. But while writing a great job ad is the first step, what's more important is increasing visibility. You could have the most detailed, well-written ad on the internet, but if no one sees it, then you are wasting time (and potentially money!). Employers often believe that job boards are the root of the problem, but you can learn how to increase job ad exposure by tweaking a few steps of your recruitment process.
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Building a candidate pipeline through a great internship program for local college students and recent graduates at local universities is a great and cost-effective way to attract and retain top talent. By offering meaningful and impactful work experiences, regular feedback, coaching, and mentorship, you can create a positive internship experience that will make your organization a sought-after destination for future employees. This not only benefits the organization in the short-term but also in the long-term, as you'll have a pool of well-trained and experienced candidates who may be interested in full-time employment once they graduate. Furthermore, building relationships with local universities and college students can increase brand awareness and build a positive reputation for your organization in the local community.
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