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Working knowledge of FDA/QSR, ISO/EU MDR standards, process validation, product design control, CAPA, and FMEA methodologies. Maintain supplier quality records in accordance with FDA/GMP and EU MDR requirements.
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Strong emphasis on exceeding customer expectations, while maximizing value to Integra and maintaining FDA/ISO compliance. Experienced with ISO and FDA quality systems regulations and medical design and development cycles.
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Quality Management Systems (QMS): Maintain and improve the QMS documentation, ensuring alignment with regulatory standards (e.g., FDA, ISO). Strong understanding of document control principles, quality management systems, and regulatory requirements (e.g., FDA, ISO.
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Ensure compliance of establish Quality Management System (QMS) and in compliance with corporate requirements and all applicable FDA Part , Part /, Part , ISO and Canadian Medical Devices Regulations (CMDR SOR/-), EU Medical Device Regulation.
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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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Strong working knowledge of ICH, FDA, ISO and cGMP regulations. This position is responsible for the oversight and management of the deliverables of the Quality Assurance, Document Control, and Quality Supplier Management departments which includes disposition of in-process materials and finished product, labeling and documentation, deviations, CAPAs and product complaints.
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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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Experience with FDA, ISO, and IEC standards a plus. Job Function: The Manufacturing Engineer will drive Engineering requirements within our medical device client's Operations team and play an active part in cross functional support, including Quality, R&D and Regulatory Affairs.
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Oversee implementation and adherence to cGMP, ICH, FDA, and ISO quality standards. Provide strategic oversight and leadership for the Quality Assurance, Document Control, and Quality Supplier Management departments.
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8+ years of experience working in an FDA/ISO regulated medical device/medical equipment environment. Founded by Harvard-research scientist, Dr. Francesco Pompei, over three decades ago, Exergen Corporation is based in Watertown, Massachusetts, USA.
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Experience with medical device development under FDA Quality Systems Regulations, CE Marking, and ISO Quality Systems. Experience with medical device development (Class II/III) under FDA Quality Systems Regulations.
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Strategic planning for annual plans to ensure that the business complies with ISO, FDA, EPA, OSHA and all other legal requirements. Passionately drive a lean operating system mentality and culture in a highly structured and prescriptive way leading the development and implementation of the roadmap to achieve breakthrough operating performance (5S, SMED, TPM, etc.
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Working knowledge of FDA, ISO, CLIA and CAP regulations. involving FDA regulated products. The Senior Project Manager, Portfolio and Program Management is responsible for the planning and execution of new biopharma clinical product development projects and/or lab expansion projects, as well as other business critical initiatives.
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Design Assurance Engineer Responsibilities: Ensuring that the design process complies with relevant regulations and standards such as FDA guidelines, ISO standards, and other applicable regulatory requirements.
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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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