Regulatory Compliance Engineer

2 weeks ago


Springdale, Arkansas, United States NOWDiagnostics | NOWDx Full time

Job Title: Quality Assurance Specialist

Department: Quality

Reports To: DOQ

Position Summary:

The Quality Assurance Specialist collaborates closely with the engineering team to identify critical quality design attributes and specifications. This role involves conducting thorough reviews to ensure that products meet essential regulatory standards. The Specialist will assist in the development, monitoring, and enhancement of ISO 13485 and 21 CFR 820 quality system procedures, ensuring that compliance requirements are fulfilled efficiently and effectively in alignment with NOWDiagnostics | NOWDx objectives.

Duties & Responsibilities:

  • Identifying factors for quality enhancement.
  • Ensuring adherence to quality standards throughout processes.
  • Compiling reports through data collection, analysis, and summarization.
  • Meeting deadlines for product delivery.
  • Actively engaging in root cause analysis for failures and CAPAs.
  • Gathering, organizing, monitoring, and disseminating information related to supplier quality and process improvement initiatives.
  • Documenting procedures and work instructions in accordance with corporate and ISO standards.
  • Establishing and executing process control plans, including capability studies and Gage Repeatability and Reproducibility (Gage R&R) studies.
  • Providing quality-related documentation to the manufacturing floor, such as control plans, control cards, visual aids, and work instructions.
  • Monitoring production processes for compliance with control plans and customer specifications, including fit, function, reliability, durability, and reappearance criteria.
  • Developing incoming inspection protocols and documenting inspection activities. Offering in-process QA support, including inspection and document review.
  • Tracking nonconforming materials and leading Material Review Board (MRB) activities.
  • Taking a lead QA role in interactions with suppliers, contractors, and consultants supplying components, subassemblies, and contract processing.
  • Leading investigations into complaints regarding returned products.
  • Ensuring timely execution of all quality inspections.
  • Engaging in activities that include authoring, issuing, and reviewing regulated documents while ensuring compliance with current Good Manufacturing Practices and 21 CFR 820.

Position Requirements:

  • Advanced proficiency in Microsoft Office Suite.
  • Exceptional communication skills, both written and verbal.
  • Strong organizational abilities.
  • Capability to work independently as well as collaboratively within a team.

Education:

  • Bachelor's degree in Engineering (or equivalent) with a minimum of 3 years of experience in the regulated medical device sector as a Quality Assurance Engineer.
  • Comprehensive knowledge of Quality Systems is essential. Practical experience with ISO 13485, FDA Quality System Regulations, Good Manufacturing Practices, Good Documentation Practices, and other relevant standards is preferred.

Note:

This job specification should not be interpreted as an exhaustive list of requirements for the position. Incumbents will follow any additional instructions and perform any related duties as directed by their supervisor.



  • Springdale, Arkansas, United States Abidi Solutions Full time

    Job OverviewPosition Title: Quality EngineerEmployment Type: Full TimeLocation: Springdale, ARDepartment: Quality AssuranceReporting Structure: Reports to DOQRole Summary:The Quality Engineer collaborates closely with the engineering team to comprehend essential quality design specifications and ensures that products adhere to necessary regulatory standards....


  • Springdale, Arkansas, United States Tyson Foods Inc. Full time

    Job Overview: POSITION SUMMARY: This role is responsible for overseeing a designated area in Transportation Safety Compliance and Training, including Fleet Maintenance Facilities, to ensure adherence to regulatory standards in alignment with Tyson Foods Inc. policies and core values. Key Responsibilities: Facilitate collaboration across various internal and...


  • Springdale, Arkansas, United States Tyson Foods Inc. Full time

    Position Overview: As a key member of the Tyson Engineering Center of Excellence, you will be part of a dedicated team of professionals who are leaders in engineering innovation and sustainability. Our mission is to deliver cutting-edge solutions that align with Tyson Foods' strategic objectives while prioritizing safety and compliance. Key Responsibilities:...


  • Springdale, Arkansas, United States Tyson Foods Inc. Full time

    Position Overview:As a pivotal member of the Tyson Engineering Center of Excellence, you will be immersed in a dynamic environment where engineering expertise meets innovation. Our team is dedicated to advancing technology and implementing cutting-edge solutions that align with Tyson Foods' strategic objectives.In this role, you will collaborate with various...


  • Springdale, Arkansas, United States Walmart Full time

    Job SummaryWe are seeking a highly skilled Senior Manager, Specialty Compliance and Ethics to join our U.S. Environmental Health & Safety (EH&S) Compliance Team. This role is critical in supporting and overseeing the management of all Industrial Hygiene and Indoor Air Quality for the Walmart U.S. Business.Key ResponsibilitiesAccess occupational health and...


  • Springdale, Arkansas, United States Tyson Foods Inc. Full time

    Position Overview:As a pivotal member of our Engineering team, you will play a crucial role in overseeing significant capital projects across our Poultry, Fresh Meats, and Prepared Foods sectors, as well as within our Warehousing & Transportation networks, with a primary focus on Civil, Structural, and Architectural (CSA) functions.At Tyson Foods, we pride...

  • Process Engineer III

    2 weeks ago


    Springdale, Arkansas, United States Raytheon Technologies Full time

    Position Overview:At Raytheon Technologies, we are on a mission to redefine the future of aviation through innovative engineering and cutting-edge technology. We are currently seeking a skilled Process Engineer III to join our dynamic Case Repair team within the Propulsion Systems Division.Role Type:This position is primarily onsite, emphasizing...


  • Springdale, Arkansas, United States Tyson Foods Inc. Full time

    Position Overview:Join our team at Tyson Foods Inc. as a key player in our Engineering Center of Excellence. We are a collective of highly skilled engineers dedicated to excellence in our fields.Our team is at the forefront of technological progress, employing cutting-edge tools and methodologies to provide effective and efficient solutions. Collaboration is...


  • Springdale, Arkansas, United States NOWDiagnostics | NOWDx Full time

    Job Title: Quality Assurance SpecialistDepartment: Quality AssuranceReports To: Director of QualityPosition Summary:The Quality Assurance Specialist plays a critical role in ensuring the quality and compliance of our medical devices. This position works closely with the engineering team to understand critical design characteristics and performs reviews to...


  • Springdale, Arkansas, United States 00100 LEIDOS, INC. Full time

    Job SummaryWe are seeking a highly skilled Cybersecurity Engineer to join our team at 00100 LEIDOS, INC. as an Information Assurance Engineer supporting the Global Solutions Management – Operations II (GSM-O II) contract at the Defense Information Systems Agency (DISA).Key ResponsibilitiesAct as a point of contact and subject matter expert for all...


  • Springdale, Arkansas, United States Abidi Solutions Full time

    Job OverviewPosition Title: Quality EngineerEmployment Type: Full TimeLocation: Springdale, ARDepartment: Quality AssuranceReporting Structure: Reports to DOQPosition Summary:The Quality Engineer collaborates closely with the engineering team to identify and understand essential quality design specifications. This role involves conducting thorough reviews to...


  • Springdale, Arkansas, United States Volkert Inc Full time

    Job OpportunityVolkert Inc is seeking a highly skilled Senior Civil Engineer Inspector to join our team in the West Gulf Region.Job SummaryWe are looking for an experienced professional to support our infrastructure projects. The ideal candidate will have a strong background in inspection, testing, and analysis of engineering-related data.Key...


  • Springdale, Arkansas, United States Walmart Full time

    Position Overview:We are on the lookout for an experienced Lead Quality Assurance Engineer specializing in Tricentis Tosca Automation and LiveCompare, possessing 7-8 years of expertise in the SAP payroll sector. The ideal candidate will demonstrate a solid grasp of Tosca automation testing techniques and a comprehensive understanding of SAP systems.Key...

  • Civil Engineer

    6 days ago


    Springdale, Arkansas, United States Gpac Full time

    Job Opportunity for a Civil EngineerWe are seeking a highly skilled Civil Engineer to join our team at GPAC, a reputable and award-winning search firm specializing in placing quality professionals within multiple industries across the United States. As a Civil Engineer, you will play a crucial role in our company's success, working on a wide variety of...


  • Springdale, Arkansas, United States Oldcastle APG Full time

    Job SummaryAs a key member of the Oldcastle APG team, the Maintenance Manager will be responsible for ensuring the development and maintenance of a comprehensive preventative and predictive maintenance program. This will involve managing the repair and fabrication of equipment for the entire facility, as well as overseeing the maintenance staff and their...

  • Welding Engineer

    2 days ago


    Springdale, Arkansas, United States Aurora Ventures Full time

    Join Our Team at Aurora VenturesAbout Aurora VenturesAurora Ventures is a leading company in the mechanical and plant engineering industry, known for its innovative approach and commitment to excellence. Our team is dedicated to delivering cutting-edge solutions that drive business growth and success.About the RoleWe are seeking a highly skilled and...


  • Springdale, Arkansas, United States NOWDiagnostics | NOWDx Full time

    Job Title: Quality Assurance SpecialistDepartment: Quality AssuranceReports To: Director of QualityPosition Overview: The Quality Assurance Specialist collaborates closely with the engineering team to comprehend critical quality design specifications and performs thorough evaluations to ensure product compliance with essential regulatory standards. This role...


  • Springdale, Arkansas, United States RTX Full time

    About the RoleRTX is seeking a skilled Dimensional Inspector to join our team in Springdale, AR. As a Dimensional Inspector, you will play a critical role in ensuring the quality and accuracy of engine cases and components.Key ResponsibilitiesPerform visual and dimensional inspections of engine cases and components to determine conformance with...


  • Springdale, Arkansas, United States RTX Full time

    About the RoleRTX is seeking a skilled Dimensional Inspector to join our team in Springdale, AR. As a Dimensional Inspector, you will play a critical role in ensuring the quality and accuracy of engine cases and components.Key ResponsibilitiesPerform visual and dimensional inspections of engine cases and components to determine conformance with...


  • Springdale, Arkansas, United States MBS Pro Staffing Full time

    Job SummaryMBS Pro Staffing is seeking a highly skilled Manufacturing Operations Resource Leader to join our team. As a key member of our operations team, you will be responsible for optimizing manufacturing processes to enhance efficiency and reduce costs.Key ResponsibilitiesProcess Optimization: Develop and implement strategies to improve manufacturing...