ISO 13485 Jobs in USA

Company: Mitsubishi Chemical Advanced Materials Inc.Job Description: TheQuality Engineer II (QEII) is a mid-level quality engineering role responsible for leading complex quality initiatives supporting cross-functional quality improvement efforts and mentoring junior quality staff. Building on found...

Position Summary:The Senior Director Companion Diagnostics (sitting onsite in Frederick MD) will be responsible for overseeing the laboratory activities for teams focused on supporting both commercially approved CDx sample analysis as well as CDx programs in development. They will use their scientif...

The Quality Systems Specialist role is responsible for supporting all areas of the pre-and post-market quality system activities; ensuring that the Quality System complies with FDA ISO and customer requirements.Role and Responsibilities:Employ quality assurance methodologies in support of quality en...

Position Summary:The Executive Director / Site Head of Precision for Medicine (located onsite in Frederick MD) will be responsible to oversee the laboratory operations across 3 different functional groups in Frederick Maryland. This role is responsible for ensuring that lab environments processes an...

We anticipate the application window for this opening will close on - 15 Jul 2026Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain restore health and extend life. Our 95000 employees work across more than 150 countries to put...

DEKA R&D on behalf of Millyard Advanced Technologiesis looking for a Product Complaints Engineer to work in a dynamic Medical Device Research and Development environment. The position reports to the Product Complaints Manager. This is a high visibility role with a significant dir...

ABOUT GENALYTEAt Genalyte were revolutionizing diagnostic testing to empower a healthier future. Genalyte is a San Diego-based diagnostics company developing the Merlin platform a novel photonic ring resonator-based system designed to deliver rapid multiplexed diagnostic results. We believe that tim...

DescriptionHi Im Will an Engineering Manager at EnsoData! Were excited to announce that were looking for a new teammate - an experienced backend engineer passionate about making healthcare better. This position offers a salary of $130000-$140000 along with bonus program stock options and benefits in...

We anticipate the application window for this opening will close on - 9 Jul 2026Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain restore health and extend life. Our 95000 employees work across more than 150 countries to put...

Value Stream Manager - MachiningorSheet MetalFull-time / PermanentRemote / With travel across US sites - 30-40%Base Salary - $167 - 208k base plus bonusAbout Us:Vantedge Medical is the premier metals-based med-tech solutions partner from concept to full-scale manufacturing. We are at the forefront o...

CNC Programmer & Setup Technician (Swiss CNC) Medical Device Manufacturing Plainview NY Full-Time On-Site About the Role: We are seeking an experienced CNC Programmer & Setup Technician to support precision manufacturing operations in a fast-paced medical device manufacturing environment. This rol...

Job TitleASL CoordinatorJob DescriptionApproved Supplier List (ASL) CoordinatorThe ASL Coordinator supports the maintenance accuracy and day-to-day administration of the Approved Supplier List (ASL) in alignment with internal Quality Management System (QMS) procedures and regulatory requirements (e....

This is whereyour work makes a difference.At Baxter we believe every personregardless of who they are or where they are fromdeserves 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...

Primary:Theposition is responsible forensuring thattheD&G QMT USfacilities andequipmentaremaintained atoperational readinessin a cGMPand ISO 13485compliant position oversees acomprehensivepreventive maintenance and equipment lifecycle program coordinates with third-party vendors and contractorsandi...

Position Overview This role supports the companys global product portfolio by maintaining registration status throughout product lifecycles championing key functions of the Quality Management System and executing supplier qualification and performance activities. The Quality Engineer serves as a lia...

Job Title: Quality EngineerLocation:Stockton CAEmployment Type:Full-Time / ExemptAbout Us:Vander-Bend is a U.S.-based manufacturer dedicated to building the precision infrastructure that powers tomorrows AI. Our expertise in server racking and power delivery solutions provides the backbone for next-...

The Senior Supplier Quality Engineer (Sr. SQE)is responsible forensuring the quality compliance and performance of external suppliers and contract manufacturers supporting medical device production. This roleoperatesindependently leads cross-functional supplier quality initiatives and drives continu...

POSITION SUMMARY The Senior Quality Systems Engineeris responsible formaintaining improving and ensuring complianceofthe Quality Management System (QMS) in alignment with applicable medical device regulations (e.g. FDA QMSR/21 CFR Part 820 ISO 13485 MDSAP). This roleoperatesindependently leadscross-...

Primary Responsibilities and Essential Job Functions: Ensure compliance with all environmental health and safety procedures policies and practices. Maintain a safe working environment for all employees. Identify and escalate safety issues immediately.  Manufacture products to required product specif...

The Senior Quality Engineer Medical Device External Quality is part of AbbVies External and Product Quality Assurance group and reports to the Senior Manager Medical Device External Quality.  The role will be based out of Lake County IL site or Pleasanton CA. This role primarily oversees external pr...