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Knowledge of FDA QSR's and ISO regulations is helpful. Create new manufacturing documentation and updating/enhancing existing documentation which conform to Quality System Regulations (QSR's) ISO Standards.
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Creates and enforces safe work practices Develops and administers department pay plans and budgets Qualifications: Strong knowledge of SMT processes, equipment, and industry best practices Working knowledge of basic printed circuit board design and concepts Working knowledge of GMP and ISO requirements.
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Support and enforce company goals and objectives, policies and procedures, Good Manufacturing Practices, Good Documentation Practices, FDA QSR and ISO regulations. Knowledge of FDA QSR and ISO regulations required.
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Familiarity with medical device development processes, FDA regulations, and ISO standards. We are seeking a highly skilled and motivated Lead Software Engineer to play a key role in the design, development, and implementation of software solutions for our medical devices.
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Previous Co-op experience in Quality Assurance within an FDA, ISO or other regulated environment preferred. Your Talent Acquisition Specialist can share more about the specific salary range for your preferred location during the hiring process.
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Knowledge of GMP, FDA, ISO requirements. Quality assurance, Compliance, GMP, Document control, Batch Record, Batch Record Review, product release, investigations, Root cause analysis, iso 13485, audit, quality compliance.
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Ensure that testing meets international and domestic biocompatibility test requirements according to ISO, Good Laboratory Practices (GLP), FDA, EU MDR, Japan, and APAC countries. Ten or more years of biocompatibility of materials related experience including biomaterials, materials science, polymer chemistry and/or analytical chemistry.
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Experience with FDA, ISO, and IEC standards a plus. Experience with FDA, ISO, and IEC standards a plus. Provide ongoing day to day support to Production; continually seek to drive improvement in operation performance while also maintaining highest levels of regulatory conformance.
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And continuous improvements and compliance of Quality Management Systems (QMS) following FDA and ISO regulations. as “Management Representative”, leading all regulatory inspections related to medical device and combination products (FDA/ISO.
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Ensure all procurement activities adhere to relevant industry regulations, including FDA and ISO standards. Monitor and manage supplier performance, ensuring on-time delivery and quality assurance.
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Responsible for product family specific systems and documentation which contribute to an effective complaint system compliant with FDA, ISO and Worldwide standards. Familiar with FDA, ISO and Worldwide standards & regulations.
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Requirements: A minimum of 5 years in medical device Quality with at least 4 years in an Engineering role Must demonstrate a working understanding of the pertinent Quality Systems Regulations (i.e.: Good Manufacturing Practices, ISO, FDA.
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Experience developing medical devices in an ISO and FDA regulated environment is preferred. Experience developing medical devices in an ISO and FDA regulated environment is preferred. If you are looking for a Senior Electrical Engineering opportunity with room to grow into a leadership position, this is the role for you - Please Apply.
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EM sampling can help to demonstrate the overall state of microbiological control within a cleanroom environment and provides our clients with crucial data to be able to maintain regulatory requirements (i.e., ISO, A2LA, FDA, EU, USP, etc.
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Knowledge of ISO, FDA, and QSR concepts and guidelines as well as other national and international regulations and standards. Participate in FDA inspections, ISO Registration and surveillance audits and customer audits.
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