Quality Assurance Nurse, Sr. jobs in the United States

Quality Assurance Nurse, Sr. evaluates the quality of patient care. Monitors compliance with current laws, process improvements, and implementation of clinical best practices. Being a Quality Assurance Nurse, Sr. reviews and analyzes customer complaints. Helps train staff on new or improved clinical practices. Additionally, Quality Assurance Nurse, Sr. requires an associate's degree/bachelor's degree and is licensed to practice nursing. Typically reports to a manager or head of a unit/department. To be a Quality Assurance Nurse, Sr. typically requires 4 to 7 years of related experience. Contributes to moderately complex aspects of a project. Work is generally independent and collaborative in nature. (Copyright 2024 Salary.com)

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Sr. Manager - Quality Assurance
  • Atrion Corporation | Halkey Roberts Corporation, Quest Medical, Inc., Atrion Medical Products
  • Allen, TX FULL_TIME
  • Summary:        The Sr. Manager of Quality Assurance leads the Quality Operations and Quality Engineering teams to ensure exceptional product quality and regulatory compliance. This role involves strategic project management to balance multiple projects with competing priorities. Key responsibilities include developing Quality Control Plans, utilizing data to enhance Quality Control and CAPA operations, and validating test methods. The manager reviews and approves critical documents such as Device History Records, SOPs, Validation Protocols, Deviation Reports, and CAPA Reports to ensure operational support and compliance. Additionally, the Sr. Quality Assurance Manager manages environmental monitoring in production areas, oversees sterilization validation activities, and leads root cause analysis investigations for effective CAPA resolution. The role also involves qualifying and monitoring suppliers, deploying risk mitigations to ensure product safety, and participating in regulatory inspections and customer audits. Continuous innovation and improvement of testing methods and processes are essential aspects of this position.   General Duties and Responsibilities:   Manages and develops the Quality Operations and Quality Engineering leadership staff. Utilize project management strategy at a department level to successfully execute multiple projects with competing resources and prioritization Develops effective Quality Control Plans to assure world-class product quality. Utilizes data as related to the Quality Control and CAPA operations. Develops and validates test methods, performs data analysis, and writes/revises SOPs.  Reviews and approves documents, including Device History Records, Standard Operating Procedures, Validation Protocols and Reports, Deviations, Engineering Change Requests, and Non-Conforming Materials Reports, CAPA Reports, Complaint investigations and Supplier Corrective Action Reports to ensure operational support and compliance. Manages the environmental monitoring program in applicable production areas, including sterilization validation and re-validation activities.  Leads root cause and failure analysis investigations to ensure effective CAPA resolution. Continuously innovate and improve methods and processes.  Defines optimum approaches in testing and analyzing data for each test being performed. Acts as assistant to Management Representative during customer and regulatory audits.  Participates in regulatory inspections and customer audits.  Qualifies new suppliers as needed and perform routine supplier monitoring activities. Deploys effective risk mitigations to assure product safety and efficacy.       Qualifications: Bachelor’s degree in a technical or scientific discipline is required. A minimum of ten years of experience in a quality or regulatory position, preferably in the medical device industry. Experience with EO sterilization processes, sterile product assembly and packaging, and electronics assembly preferred. A minimum of five years of management experience or 10 years in a quality leadership role. Excellent working knowledge of the FDA’s 21 CFR Part 820; ISO 13485; EU Medical Device Directive (93/42/EEC); Canadian Medical Devices Regulation (SOR98-282); Japanese MHLW Ordinance 169; RDC ANVISA 16/2013, Australian TG(MD)R, ISO 14971, ISO 9001, and Medical Device Single Audit Program (MDSAP). Experience with IEC 60601 preferred. Experience in supporting FDA inspections as a quality system subject matter expert and an ability to interpret regulatory requirements. Detail oriented and possess a professional demeanor, be adaptable to changing environments, handle diverse workloads, and capable of completing tasks with little or no supervision. Demonstrated ability to work in a highly cross-functional environment. Excellent technical writing experience within a medical device environment is essential. Strong root cause analysis skills. Ability to use sound scientific judgement and risk management for the facility to prevent regulatory action. The ability to work with minimal supervision to prioritize tasks and be able to manage several projects and tasks simultaneously to meet deadlines; and the ability to interface with all levels of management. Certified Lead Auditor or ASQ certification as a Certified Quality Auditor (CQA), Certified Quality Engineer (CQE) strongly preferred.
  • 1 Month Ago

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Sr Quality Assurance Analyst
  • Republic Services
  • Phoenix, AZ FULL_TIME
  • ABOUT THE COMPANYRepublic Services, Inc. (NYSE: RSG) is a leader in the environmental services industry. We provide customers with the most complete set of products and services, including recycling, ...
  • 1 Month Ago

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Sr. Quality Assurance Engineer
  • Advent Software, Inc.
  • Jacksonville, FL FULL_TIME
  • SS&C is a global provider of investment and financial services and software for the financial services and healthcare industries. Named to Fortune 1000 list as top U.S. company based on revenue, SS&C ...
  • 1 Month Ago

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Sr. Specialist, Quality Assurance
  • 225 Cardinal Health 414, LLC
  • Memphis, TN FULL_TIME
  • Cardinal Health PET Manufacturing Services is responsible for manufacturing PET radiopharmaceuticals to enhance patient treatment through improved disease diagnosis, staging, and monitoring. The prima...
  • 1 Month Ago

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Sr. Specialist, Quality Assurance
  • Cardinal Health
  • Memphis, TN FULL_TIME
  • Cardinal Health PET Manufacturing Services is responsible for manufacturing PET radiopharmaceuticals to enhance patient treatment through improved disease diagnosis, staging, and monitoring. The prima...
  • 1 Month Ago

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Sr Quality Assurance Engineer
  • ClearOne Advantange
  • Baltimore, MD FULL_TIME
  • Senior Quality Assurance Engineer We are looking for a Senior Quality Assurance (QA) engineer to develop and execute exploratory and automated tests to ensure product quality. QA engineer responsibili...
  • 1 Month Ago

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Assistant Director of Nursing - RN (Evening)
  • Advanced Recovery Systems
  • Columbus, OH
  • Overview: We are looking for dynamic and compassionate Assistant Director of Nursing (RN) to join our TEAM in Columbus, ...
  • 10/31/2024 12:00:00 AM

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Accreditation Officer
  • The Ohio State University
  • Columbus, OH
  • Screen reader users may encounter difficulty with this site. For assistance with applying, please contact hr-accessiblea...
  • 10/31/2024 12:00:00 AM

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Home Health Director of Quality Outcomes
  • FC Compassus LLC
  • Columbus, OH
  • Company: OhioHealth at Home Position Summary The Home Health Director of Quality Outcomes is responsible for modeling th...
  • 10/31/2024 12:00:00 AM

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Revenue Cycle Manager
  • Ohio State University Physicians, Inc.
  • Columbus, OH
  • Overview: Looking to join and lead a dynamic team at Ohio State University Physicians where excellence meets compassion!...
  • 10/31/2024 12:00:00 AM

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Nurse Account Manager
  • Guardian Pharmacy, LLC
  • Columbus, OH
  • Columbus, Ohio, United States of America Extraordinary Care. Extraordinary Careers. With one of the nation's largest, mo...
  • 10/30/2024 12:00:00 AM

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Medical Director
  • Lighthouse Behavioral Health Solutions
  • Columbus, OH
  • Join Our Team! We are excited to announce we are opening a brand-new residential treatment facility in Columbus, Ohio an...
  • 10/30/2024 12:00:00 AM

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LPN
  • Fresenius Medical Care
  • Columbus, OH
  • Replacing with a LPN PURPOSE AND SCOPE: Functions as part of the dialysis health care team in providing safe and effecti...
  • 10/29/2024 12:00:00 AM

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Patient Care Technician
  • Fresenius Medical Care
  • Columbus, OH
  • PURPOSE AND SCOPE: Functions as part of the dialysis health care team in providing safe and effective dialysis therapy f...
  • 10/29/2024 12:00:00 AM

Income Estimation for Quality Assurance Nurse, Sr. jobs
$97,534 to $114,889