Quality Systems Compliance Specialist - Medical Device
Avanos Medical
Avanos Medical seeks a Quality Systems Compliance Specialist to support and enhance our global medical device quality system. In this role, you will maintain compliance with FDA, ISO 13485, and other regulatory requirements by managing quality documentation, change control, and internal audit activities. You will investigate nonconformances, support CAPA and risk management, and partner with cross-functional teams to drive continuous improvement. The specialist will analyze quality metrics, prepare inspection-ready records, support regulatory inspections, and train staff on quality procedures, helping ensure safe, effective products for patients worldwide.
- ...analytical individual to join our team as a Specialty Claims Quality Assurance and Compliance Senior Specialist. This role will report to the VP, Specialty Claims... ...handling decisions.Working knowledge of claims systems and tools, including Guidewire ClaimCenter and...Suggested
- ...- Regulatory Affairs Specialist Job Title: Regulatory... ..., biotechnology, or medical device products. The ideal... ...submissions, ensure compliance with global regulatory... ...with Clinical, Quality Assurance, Manufacturing... ...electronic submission systems such as eCTD. Knowledge...Medical deviceWork at officeLocal areaRemote workFlexible hours
$100k - $118k
...leading hospitals, health systems and research centers around... ...offerings1,000 branded medical product suppliers4,000 healthcare... ...global program to audit quality systems and compliance areas such as FCPA and an... ...specifically with medical devices.Manages and maintains an...Medical deviceFull timeTemporary workLocal areaWorldwide- ...delivers rapid testing and point-of-care medical device solutions used in the detection of... ...Protocols & Performance Testing 4. Quality & Compliance Laboratory & Technical Responsibilities... ..., controlled forms, and electronic systems in compliance with quality system requirements...Medical deviceFlexible hours
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- ...cost optimization initiatives. Ensuring all work is conducted in compliance with FDA Quality System Regulations, internal quality standards, and product safety requirements for Class II medical devices. Establishing project timelines, learning plans, resource...Medical deviceFull timeLocal areaRemote workRelocation packageFlexible hours
- ...Senior Quality Engineer Mativ is a global leader in specialty... ...interface for customers in the Medical Devices, Healthcare, and Hygiene... ...proposed changes on quality, compliance, performance, and customer expectations... ...the Quality Management System. Verify the effectiveness of...Medical device
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- ...Description Job Title: Quality Assurance Specialist – Product Operations... ...the quality, compliance, and reliability of... ...cardiac monitoring devices and related workflows... ...intersection of quality systems and day-to-day... ...cadence of a distributed medical device company. Key...Medical deviceRemote work
- ...delivers rapid testing and point-of-care medical device solutions used in the detection of... ...: We are seeking an experienced Quality Assurance Manager to lead our quality... ...background in quality management systems, regulatory compliance, and team leadership. Key Responsibilities...Medical device
$20 - $25 per hour
...Data Entry Specialist Company: American BOA Location: 1485 Redi Road, Cumming, GA 30... ...industrial. We are committed to innovation, quality, and customer satisfaction, and we are... ...various types of data into our computer systems. This role requires exceptional...Hourly payFull timeWork at officeMonday to FridayFlexible hours- ...materials and innovative solutions for the medical device industry. We partner with leading... ...With deep expertise in complex catheter systems, cardiovascular applications, and CDMO... ...: Collaborate closely with Sales, R&D, Quality, Regulatory, Operations, and Marketing...Medical device
$102.1k
...Boston Scientific, we believe quality is fundamental to patient... ...product quality, regulatory compliance, and continuous improvement.... ...with Boston Scientific Quality System requirements and applicable... ...Systems, and applicable medical device regulatory requirements....Medical deviceHourly payRelocationShift work- ...Corporation in Buford, GA is seeking a Quality Inspector responsible for incoming inspection... ...audits, and maintaining quality system requirements. Requires high school diploma... ...preferred; 2-3 years related experience; medical device manufacturing experience preferred. #J-...Medical device
$53.04k - $60.32k
...Engineering Technician to support top medical laboratory in Norcross, GA!... ...protocols and within quality control limits. + Maintain strict... ..., biologics, medical device, clinical diagnostics, or medical... ...understanding of applicable quality and compliance requirements. Job Type &...Medical devicePermanent employment- ...delivers rapid testing and point-of-care medical device solutions used in the detection of... ...Position Summary The Regulatory Affairs Specialist will support the preparation, review,... ...device/IVDs products, ensuring compliance with applicable regulatory requirements...Medical deviceFlexible hours
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$118k - $196.7k
...The Manager, Quality Operations will oversee quality-related... ...continuous improvement and compliance. Partner with site leadership... .... Drive quality system compliance by partnering with... ...6 years of experience in a medical device, pharmaceutical, biomedical,...Medical deviceFull timeFixed term contractLocal area- ...review process. Follow applicable quality, regulatory, compliance, credentialing, and commercial... ...more years of successful hospital medical-device sales experience. Demonstrated success... .... Proficiency with CRM systems and standard business productivity...Medical deviceFull timeContract workLocal areaNight shiftWeekend workAfternoon shift
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- ...delivers rapid testing and point-of-care medical device solutions used in the detection of... ...maintenance, troubleshooting building system issues, and responding to repair needs.... ...• Maintain maintenance logs and safety compliance records. Emergency Response & Tenant...Medical deviceWork at officeFlexible hours
$24 - $26 per hour
...We are seeking a Quality Assurance Specialist to support Quality Management System activities within a manufacturing environment... ...activities while ensuring compliance with GMP and GLP... ...experience , preferably within the medical device industry . ~ Knowledge of...Medical deviceContract workShift work- Avanos Medical seeks an Associate Director, Commercial Technology & Innovation to lead digital solutions that accelerate growth across... ...prioritize initiatives, manage vendors, and ensure secure, compliant systems that support patient-focused outcomes. The role includes...Medical device
- ...Facilities Engineer Chemence Medical, Inc. seeks Facilities... ...maintenance of facility and utility systems that support chemical... ...control systems. Supports compliance with applicable federal, state... ...engineering role working in a medical device manufacturing environment....Medical deviceLocal area
- ...HR, and benefits for a network of market centers and depots in the U.S. You will ensure compliance with wage, hour, and tax laws and manage data entry in HRIS and timekeeping systems. This role requires attention to detail, ability to handle multiple tasks, and...
$66.56k - $75k
...100 countries, CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of infectious disease such as... ...Complete sales order and purchase order entry into the SOS inventory system. Keep detailed records of shipment details. Follow up on and...Medical deviceFull time- ...appropriate functions. Support operations and quality teams in continuous improvement... ...in a manufacturing environment. Medical device manufacturing experience including FDA-... ...Experience manufacturing emulsions, surfactant systems, suspensions, and powders....Medical deviceWork at office
$160.7k - $298.4k
...results analysis. Provide inputs to FPGA, system, and PCB design requirements. Support... ...characterization of high speed and/or memory IO devices, exposure to DDRx characterization is... ...Software and Aerospace to AI, Clean Tech, Medical Devices, and Connected Technologies. We'...Medical device3 days per week$175k
...educational meetings; ensure regulatory compliance Requirements Bachelor's degree in... ..., or related field Minimum 6+ years medical device sales experience Minimum 3 years... ...understanding Proficient in MS Office and CRM systems Knowledge of peripheral vascular...Medical deviceBase plus commission
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