Iso 13485 jobs in north carolina

Remote

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Today

Validation Engineer Remote Long Term Contract validation engineer utilizes validation and integration strategies to assure manufacturing equipment, computer/automated systems (software), utilities and processes used to manufacture Client s Health products are validated in accordance with applicable national and international regulations, Client s Health policies and procedures, and industry standards. This individual will assist the company to develop and implement operating procedures associate

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Third Party, Contract

Depends on Experience

Engineering Manager

Charlotte, North Carolina

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Today

Manufacturing Engineering Manager - Medical Devices This Jobot Job is hosted by: Matt Swaneveld Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume. Salary: $130,000 - $160,000 per year A bit about us: Based in Charlotte, NC, we are a growing medical device manufacturer in need of a hands on Engineering Manager. Why join us? Competitive Compensation Medical Device Innovation: Work on complex product development, manufacturing, and design-transfer proj

Full-time

USD 130,000.00 - 160,000.00 per year

FDA Medical Validation Engineer - Remote

Remote

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Today

Job Title: FDA Medical Validation Engineer Remote Contract Position Description The validation engineer utilizes validation and integration strategies to assure manufacturing equipment, computer/automated systems (software), utilities and processes used to manufacture Client s Health products are validated in accordance with applicable national and international regulations, Client s Health policies and procedures, and industry standards. This individual will assist the company to develop and im

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Contract

Depends on Experience

Loftware Spectrum Technical Lead / Solution Engineer

Remote

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11d ago

At NTT DATA, we know that with the right people on board, anything is possible. The quality, integrity, and commitment of our employees have been key factors in our company's growth and market presence. By hiring the best people and helping them grow both professionally and personally, we ensure a bright future for NTT DATA and for the people who work here. For more than 25 years, NTT DATA Services have focused on impacting the core of your business operations with industry-leading outsourcing

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Contract

Depends on Experience

PLM Windchill Solution Architect/ SME

Remote

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Today

Position SummaryWe are seeking a highly experienced Windchill PLM Subject Matter Expert to assess the current PTC Windchill environment and develop a strategic upgrade roadmap for Windchill 2027. The ideal candidate will have strong technical and functional expertise in Windchill, PLM transformation, system upgrades, data migration, and integrations within regulated industries, preferably Medical Devices. Key ResponsibilitiesAssess the existing Windchill environment, including configurations, cu

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Contract, Third Party

Depends on Experience

Technical Project/Program Management - Technical Program Manager V

Remote

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Today

Job#: 3053591 Job Description: Technical Project/Program Management - Technical Program Manager V Compensation: $12- - $130 hourly Location: Remote, California (Remote) Role Overview We are seeking a senior Technical Program Manager with relevant Software as a Medical Device (SaMD) experience. This role focuses on managing the software release process for a key medical device feature. The position requires leading cross-functional teams to ensure deliverables are completed in accordance wit

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Full-time

$120 - $130 per hour

GRC Analyst

Remote

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4d ago

This is a 3 Month Contract to Hire Opportunity. This position is 100% Remote. This is an outstanding opportunity for a Sr. GRC Analyst to participate in large global GRC initiatives that literally save lives. We are a leading global biotech company committed to improving human health through scientific innovation. With a 50+ year legacy of excellence, our publicly traded organization employs over 7,000 global team members, holds 750+ product patents, and generates $6.6 billion in revenue with $1

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Contract

$60 - $70

Principal National Support Engineer II

Remote

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Today

Position Overview The Principal National Support Engineer II provides the highest level of technical expertise and experience to the Fujifilm Healthcare Medical Informatics business covering all currently offered products including, but not limited to: storage systems, PACS (Radiology/Cardiology), VNA, Mobility, 3D Systems, Syncomm and Clinical Information Systems. While this position primarily supports the Technical Assistance Center (TAC), technical leadership and direction is provided to all

Full-time

USD 110,366.00 - 130,909.00 per year

Sr CAPA Engineer

Remote or Waltham, Massachusetts

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Today

PURPOSE AND SCOPE: Lead the harmonization and standardization of the product transfer process including execution and oversight of the product transfer process for assigned regional/global area. PRINCIPAL DUTIES AND RESPONSIBILITIES: Develop, implement, and maintain Global Product Transfer processes for design and manufacturing product transfer.Ensure product quality is achieved at the receiving manufacturing site level during product transfer projectsPartner with CE vertical quality, R&D team

Full-time

Senior Process Engineer - Compliance #4968

Durham, North Carolina

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Today

Our mission is to detect cancer early, when it can be cured. We are working to change the trajectory of cancer mortality and bring stakeholders together to adopt innovative, safe, and effective technologies that can transform cancer care. We are a healthcare company, pioneering new technologies to advance early cancer detection. We have built a multi-disciplinary organization of scientists, engineers, and physicians and we are using the power of next-generation sequencing (NGS), population-scal

Full-time

USD 95,000.00 - 125,000.00 per year

Oracle DBA (National Support Engineer role for Medical Imaging)

Remote

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Today

Position Overview The Distinguished National Support Engineer provides the highest level of technical expertise and experience to the Fujifilm Healthcare Medical Informatics business covering all currently offered products including, but not limited to: storage systems, PACS (Radiology/Cardiology), VNA, Mobility, 3D Systems, Syncomm and Clinical Information Systems. While this position may provide direct support to the Technical Assistance Center (TAC), the primary focus is technical leadership

Full-time

USD 110,366.00 - 146,364.00 per year

Sr. Software Systems Engineer

Raleigh, North Carolina

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Today

This is where your work makes a difference. At Baxter, we believe every person-regardless of who they are or where they are from-deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboratio

Full-time

USD 104,000.00 - 143,000.00 per year

Sr. Principal Software Systems Engineer - Relocation Assistance

Raleigh, North Carolina

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Today

Full-time

USD 144,000.00 - 198,000.00 per year

Loftware Spectrum Technical Lead / Solution Engineer

Remote or Plano, Texas

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Today

Full-time

Imaging Service Engineer I - Minnesota

Remote

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Today

Position Overview An Imaging Service Engineer I is responsible for performing scheduled service work on systems within a service area, and some unscheduled work in the service area with the assistance of technical support, as directed by the Area Service Manager. Company Overview At FUJIFILM Healthcare Americas Corporation, we're on a mission to innovate for a healthier world, and we need passionate, driven people like you to help us get there. Our cutting-edge healthcare solutions span diagno

Full-time

USD 32.69 - 38.46 per hour

Software Test Engineer, GRD

Durham, North Carolina

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Today

Position Overview This position is intended to test and support the software in order to provide a competitive product to the company. In addition, you will use manual and tool assisted testing of new and existing features in medical device software systems. Company Overview At FUJIFILM Healthcare Americas Corporation, we're on a mission to innovate for a healthier world, and we need passionate, driven people like you to help us get there. Our cutting-edge healthcare solutions span diagnostic

Full-time

Product Development Engineer

Charlotte, North Carolina

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Today

Work Schedule Standard (Mon-Fri) Environmental Conditions Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Setting, Loud Noises (Equipment/Machinery), Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) Job Description As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Joi

Full-time

Sr. Computer Systems Validation Engineer

Remote or Trumbull, Connecticut

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Today

Job Description Scope: The Senior Computer Systems Validation Engineer is responsible for validation of global computer systems, monitoring changes with regulations, and assists team members for CSI's corporate Computer Systems Validation (CSV) strategy to meet all applicable regulations. Job Summary: The Senior Computer Systems Validation Engineer provides strategic leadership and technical expertise for the validation, maintenance, and continuous improvement of computerized systems used in

Full-time

USD 96,441.00 - 126,000.00 per year

Equipment Validation Engineer 2

Durham, North Carolina

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Today

Position Overview We are seeking an Equipment Validation Engineer II to support the qualification of manufacturing equipment and utilities in our GMP facility. You will develop and execute risk-based validation strategies, author and run IQ/OQ/PQ protocols, and partner with cross-functional teams to ensure compliant, reliable operations. Company Overview At FUJIFILM Biotechnologies, we're leading the charge in advancing tomorrow's medicines. If you want to be a part of life-impacting projects

Full-time

Senior Product Quality Assurance Engineer (I&G)

Remote

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Today

The Senior Design Quality Engineer ensures that new and existing digital health products from Incubation & Growth (I&G) areas comply with quality, safety, regulatory standards, and user requirements. He/She is specialized in design controls, overseeing verification and validation activities in alignment with internal quality management systems and external regulations. He/She should understand emerging technologies as part of I&G and supports the strategy from concept to commercial launch. What

Full-time

USD 122,000.00 - 184,000.00 per year

Iso 13485 jobs in North Carolina, USA