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Provide regulatory perspective of internal and external documentation to support the development and commercialization of assigned product(s). Author IDEs, 510(k), PMAs, Technical Files or Design Dossiers Work on risk assessments with cross functional teams.
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We prepare NEPA documents, conduct noise and air quality studies, develop sustainability plans, evaluate and develop mitigation plans for environmental impacts, contribute to environmental documentation, engage the public, and ensure regulatory compliance.
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Able to review documentation and determine results based on COBRA laws and guidelines. Write and Review Performance related documentation, with the assistance of your Director, Annual reviews, Performance Improvement Plans, Warnings, etc.
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Strong leadership, communication and writing skills with the ability to author detailed reports and documentation as well as to synthesize technical information and present it to specialists and non-specialists.
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Create and update documentation including BOMS, assembly procedures, test procedures, and drawings in support of instrumentation manufacturing. Participate in the development and maintenance of Process Failure Mode and Effects Analysis (pFMEA) and other associated risk documentation.
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The job purpose and scope of the Clinical Research Scientist is to author the scientific documents associated with design, conduct, and reporting of clinical trials in the therapeutic area of Heart Failure, particularly mechanical circulatory support and hemodynamic monitoring.
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Preferred:Master’s degree in electrical engineering, biomedical engineering, or related fieldUnderstanding of good documentation practicesExperience with battery technologies and solutionsProject Management skillsAt least one year of hands-on analog & digital circuit design experience for embedded systems.
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RequirementsTooling, Supply Management, Mechanical Inspection Tools, Technical Understanding, Attention to Detail, Dependability, Thoroughness, Verbal Communication, Documentation Skills, Inventory Control, Job KnowledgeLocationHerb Chambers Kia of BurlingtonSalary Range.
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Preferred to have 2 years experience as final QA Approver of Quality Systems related documentation such as but not limited to change controls, deviations, nonconformances, internal audit reports, CAPA reports, document change reports, protocols, technical reports, project plans, and quality improvement plans.
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Prepare and review documentation for current processes, pain points, and assumptions for finance systems. Experience with RESTful and SOAP web services along with standard API integration tools (e.g. MuleSoft, Boomi.
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It is an integral part of Cambridge’s fast paced, dynamic Functions: Receiving – unloading trucks, verifying proper documentation, process, organize and distribute and stock as needed. Shipping Back Up – packing and organizing parts for shipments, loading trucks, completing required paperwork ensuring proper documentation, etc.
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Documentation of registration for next NCCPA Board administration or successful completion of NCCPA Board and maintenance of appropriate CME.- Advanced Cardiovascular Life Support (ACLS) certification required.
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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. Qualify and/or Validate fixtures, tooling and systems via IQ/OQ/PQ, Gage R&R and Process Capability Studies.
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Provision of any health documentation that might be required by regulatory agencies (Serve Safe certification, Allergy Awareness certification. Must demonstrate ability to relate to a substance abuse treatment population in a sensitive manner, an interest and willingness to work in a multicultural setting.
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Adhere to clinical recommendations from clinical administrationMaintain confidentiality in all clinical mattersRemain compliant with billing and documentation in accordance with direct service requirementConduct visits with clients and relevant collaterals in natural environments according to the needs of the child and family Qualifications: Current licensure as a Physical Therapist Therapist by the Connecticut Board ofof Allied Health Professions.
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author documentation jobs in North Billerica, MA
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