- Plastipak Packaging, Inc. (Champaign, IL)
- Job Description As an ISO and Food Safety Leader, you will ensure that the processes needed for the quality management system are established, implemented, and ... offer job stability through market uncertainty You Will Function within the ISO /Team environment to ensure ISO /BOS compliance. Oversee the development,… more
- ASRC Federal Holding Company (Elizabeth City, NC)
- …Requirements : Bachelor's degree and four (4) years of process improvement experience that includes ISO 9001, ISO 14001 and/or ISO 45001 . Prefer a degree ... degree, eight years of process improvement experience that includes ISO audit process. Strong knowledge of one or both...and certification in one of these is a plus. ISO certification is a plus. Experience coordinating and maintaining… more
- Amcor (Warren, OR)
- …LinkedIn | YouTube Responsibilities The primary duties and responsibilities of the ISO /SQF Representative consist of, but are not limited to, the following: ... including SQF Systems. Must follow and comply with all ISO 9001, ASI - Food Safety, ISO 15378 established requirements. The authority & responsibility to promote… more
- Aptyx (Charlotte, NC)
- …testing, and interpret performance data. Working knowledge of design controls, risk management, ISO 14971, ISO 13485, and 21 CFR 820. Familiarity with relevant ... device specific standards such as ISO 10555, ISO 11070, ISO 5840, ISO 25539, and others. Strong problem solving skills with clear and concise technical… more
- PPL Corporation (Allentown, PA)
- …Transmission Operations personnel. Ensure internal compliance with FERC, NERC, PJM, ISO -NE, and PPL requirements. Monitor training methods and requirements at peer ... execute individually tailored training sessions using the simulator to maintain ISO -NE/PJM/NERC certification skill levels for all TSOs. Support the development and… more
- Oracle (Raleigh, NC)
- …healthcare solutions align with global medical device standards, including IEC 62304, IEC 82304, ISO 13485, ISO 14971 , and related IMDRF SaMD guidance. You will ... Regulatory, and Clinical teams to ensure product development conforms to ISO 13485 , ISO 14971 , EU MDR/IVDR expectations, and IMDRF SaMD risk frameworks.… more
- Teradyne (North Reading, MA)
- …knowledge of industrial automation, robotics systems, and functional safety standards such as ISO 13849, IEC 61508, and IEC 60204, along with hands-on experience in ... and Certification Interpret and apply relevant global standards, such as: ISO 12100 (Safety of Machinery) ISO 10218 / ISO 15066 (Robotics and Collaborative… more
- Merck & Co. (Rahway, NJ)
- …and ensuring alignment with global regulatory requirements (eg, FDA 21 CFR Part 820, ISO 13485, ISO 14971). - This position will interact with cross-functional ... device and drug combination products (eg, FDA 21 CFR Part 820, ISO 13485, ISO 14971) Collaborate with cross-function teams to improve processes related to… more
- Globus Medical, Inc. (Audubon, PA)
- …Quality. This position ensures compliance with applicable regulatory requirements (FDA QSR, ISO 13485, EU MDR, MDSAP, etc.) and alignment with company objectives for ... and nonconformance processes. Lead validation strategy and ensure compliance with ISO 14971, ISO 13485, and 21 CFR Part 820 requirements. Support new product… more
- Amgen (Cambridge, MA)
- …complete projects Strong technical writing skills Experience with regulatory filings/ responses authoring/ support ISO 14937, ISO 11135, ISO 11137, ISO ... 11138, ISO 10993, ISO 11737 Fast and continuous learner Ability to travel to international locations assisting our development partners during implementation of specific container requirements into their processes What you can expect from us As we work… more
- NANA Regional Corporation (Chambersburg, PA)
- …Quality Assurance (QA) Program and Quality Management System (QMS) IAW ISO 9001. Responsible for developing, establishing, implementing, and continually improving a ... compliant Quality Management System (QMS) IAW ISO 9001 within all departments on the project. This includes evaluation and continually monitoring, auditing, and… more
- Eversource Energy (Westwood, MA)
- …New England Power Coordination Council (NPCC), and Independent System Operators of New England ( ISO -NE) as needed. This is a hybrid position. The first 3 months are ... standards in conjunction with any other applicable NERC, NPCC, and ISO -NE reliability standards and criteria Determining transmission system area needs through… more
- Takeda Pharmaceuticals (Lexington, MA)
- …continuously improving our global EHS Management System. You will ensure alignment with ISO 14001 and ISO 45001 standards, simplify and standardize processes ... subject matter expert for corporate EHS management systems, ensuring alignment with ISO 14001, ISO 45001, and internal requirements. Lead the development,… more
- General Motors (Little Rock, AR)
- …provide safety guidance to a team of AI/ML developers. You will apply your experience with ISO 8800 and ISO 21448 to ensure we develop, deploy and maintain safe ... closed course and on public roads. What You'll Do (Responsibilities) Referencing ISO 8800, ISO 21448 and AV industry best practices, develop the strategy for… more
- Takeda Pharmaceuticals (Lexington, MA)
- …with applicable medical device and software regulations (eg, FDA 21 CFR Part 820, ISO 13485, ISO 14971, MDR/IVDR, MDSAP). Act as or designate the Device ... and guidances governing medical device, including FDA 21 CFR Part 820, ISO 13485, ISO 14971, MDR/IVDR, MDSAP, and global quality systems. Strong background in… more
- Hologic (Marlborough, MA)
- …and monitor a robust Internal Audit Program, ensuring compliance with FDA regulations, ISO standards, and other global regulatory requirements. If you thrive in a ... Deep understanding of FDA Code of Federal Regulations (21 CFR 820), ISO standards (eg, ISO 13485:2016, ISO 14971), MDSAP, and other global regulatory… more
- System One (Corvallis, OR)
- …Quality Assurance Specialist to support our client, in developing and implementing their ISO 19443:2018 Quality Assurance Program. This position is part of a staff ... the commercial nuclear sector. Responsibilities Develop, evaluate, and maintain ISO 19443:2018 quality assurance program processes. Write and update procedures,… more
- GRAIL (Durham, NC)
- …in compliance with GRAIL's Quality Management System procedures and regulatory requirements including ISO 13485, ISO 14971, 21 CFR 820, IVDR, CAP/CLIA/NYSDOH, ... regulations and standards, including but not limited to QSR, ISO 13485, CAP/CLIA, NYSDOH, ISO 15189, IVDR. Experience using an eQMS required; Veeva Vault… more
- Eversource Energy (Westwood, MA)
- …Coordination Council (NPCC), Independent System Operators of New England ( ISO -NE), and Regional Transmission Organizations. Job Summary Eversource Energy ... their industry peers on regional activities (eg NERC, NPCC, ISO 's, etc.). Each planner has the freedom to work...A familiarity with various planning standards (eg NERC, NPCC, ISO -NE etc.) and planning software packages such as PSS/E… more
- EY (Charlotte, NC)
- …services and integrations (Wire, ACH, RTP, EFT, etc.) Deep understanding of ISO 20022 standards, including message structures, business processes, and data elements. ... ISO Test Case Design: Ability to design comprehensive ISO test cases (CHIPS, FEDWIRE, SWIFT Payments Analyst | SWIFT GPI | WIRES | SEPA | FX|TGT2 | ISO20022|… more
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