Sign up to access all features of our service.
  • Job search
  • Favorites
  • Create a CV
    New
  • Salaries
  • Subscriptions

Design Quality Engineer - Medical Devices (FDA/ISO)

United Pharma

United Pharma in New Jersey is seeking an experienced Design Quality Engineer to join our Medical Device team. The role requires strong knowledge of design controls, product development, quality systems, and regulatory compliance to support development and commercialization of medical devices. The successful candidate will ensure compliance with FDA 21 CFR Part 820, ISO 13485, and ISO 14971, lead Design Control activities, and collaborate with R&D, Manufacturing, Regulatory Affairs, and #J-18808-Ljbffr United Pharma

Vacancy posted 2 days ago
Similar jobs that could be interesting for youBased on the Design Quality Engineer - Medical Devices (FDA/ISO) in New York, NY vacancy
  • $120k - $160k

     ...located in New York, is looking for an experienced Quality Engineer to own key quality processes as they expand....  ...candidate has over 5 years of experience in a medical device quality role and a strong understanding of ISO standards. Compensation is competitive, ranging... 
    Suggested

    Fortell

    New York, NY
    2 days ago
  • $100k - $150k

    Tempus AI is seeking a Senior Quality Engineer in New York, NY, to lead verification and validation activities for medical device software. You will ensure compliance with FDA regulations and develop validation practices. The ideal candidate has 5+ years in FDA-regulated... 
    Suggested

    Tempus AI

    New York, NY
    2 days ago
  • United Pharma is seeking a Design Assurance Quality Engineer to ensure quality and regulatory compliance in product development. The role involves...  .... Candidates should have over 6 years of experience in medical device QA, a strong design assurance background, and... 
    Suggested

    United Pharma

    New York, NY
    2 days ago
  •  ...offering an exciting opportunity for a Quality/System Engineer in the medical device industry. This role is crucial in...  ...will conduct gap assessments, lead design control processes, and maintain...  ...understanding of regulations such as ISO 13485 and EU MDR. Join a forward-thinking... 
    Suggested

    Hyper Recruitment Solutions Ltd

    New York, NY
    4 days ago
  • Dexian is looking for a Quality Engineer (Supplier Quality) in Warrendale, PA. The role involves ensuring compliance with medical device regulations through quality system support, updating supplier performance documentation, and participation in audits. Candidates should... 
    Suggested

    Dexian

    New York, NY
    2 days ago
  • A leading medical device company is looking for a Supplier Quality Engineer to ensure compliance and quality in the supply chain for Class II/III devices. Responsibilities...  .... The ideal candidate should have experience in FDA regulations and a background in continuous... 

    Intellectt Inc

    New York, NY
    1 day ago
  • $135k - $175k

     ...Senior Product Quality Engineer quip is seeking a Senior Product Quality...  ...in our DUMBO, Brooklyn design studio, with Fridays remote....  ...ensure strict adherence to ISO 13485 and ISO 9001 standards...  ...demonstrated experience auditing medical device or high-compliance consumer... 
    Full time
    Contract work
    Summer work
    Work at office
    Remote work
    Night shift
    Afternoon shift

    Quip

    New York, NY
    1 day ago
  • EPAM Systems seeks a Senior GRC & Compliance Automation Engineer to transform manual audit work into continuous, automated evidence collection...  ...collection, and enabling automated control status across SOC 2, ISO, and SOX frameworks using Python, REST APIs, and #J-18808-... 
    Remote job
    Work at office

    EPAM Systems

    New York, NY
    2 days ago
  • Overview Freelance FDA Consultant (ISO 13485 & ISO 22716 Experience) USA Remote (with occasional...  ...enables us to deliver high-quality, results-driven ISO consultancy to clients...  ...quality systems aligned with ISO 13485 (medical devices) and ISO 22716 (cosmetics GMP). What... 
    Contract work
    For contractors
    Self employment
    Freelance
    Remote work
    Worldwide
    Flexible hours

    IMSM

    New York, NY
    4 days ago
  • $101k - $152k

     ...Medline’s supplier quality oversight for a...  ...20 §820.50 and ISO 13485:2016 7.4)...  ...alignment with device regulations and...  ...Management, Design and Development...  ...procurement, engineering, and operations...  ...standards and FDA regulations Strong...  ...Strong Medical Device or Drug... 
    Minimum wage
    Work experience placement
    Local area
    Worldwide

    Medline Industries

    New York, NY
    5 days ago
  • NPAworldwide is seeking a Senior Software Quality Assurance Engineer to play a critical role in ensuring quality and compliance for innovative medical devices. This fully remote position involves leading quality activities throughout the product lifecycle, owning documentation... 
    Remote job

    NPAworldwide

    New York, NY
    2 days ago
  • Job Title: Quality Engineer (Supplier Quality) Location: Warrendale, PA (fully onsite) Duration: 07/06/2026 - 12/...  ...system processes to ensure compliance with applicable medical device regulations (FDA, EU, Health Canada, ISO 13485) by providing operations support, tracking... 
    Local area
    Monday to Friday
    Shift work

    Dexian

    New York, NY
    2 days ago
  •  ...Quality Engineer Responsible for supporting production line transfers, including creation of...  ...by internal Quality Policies and related FDA/GMP guidelines. Conducts failure analysis...  ...Regulations (i.e.: Good Manufacturing Practices, ISO, FDA). Proven ability to develop... 

    Pyramid Consulting

    New York, NY
    1 day ago
  • $155k - $190k

     ...legal judgment. Your Impact A Compliance Engineer on our growing DevOps team will drive the...  ...contact for annual SOX, SOC2 Type II, and ISO-27001 audits while automating evidence...  ...and fun environment. Benefits, including medical, dental and vision insurance, as well as... 
    H1b
    Visa sponsorship
    Flexible hours

    Disco

    New York, NY
    5 days ago
  • $25 per hour

    A medical device consulting firm is seeking an entry-level Project Engineer specializing in Regulatory, Clinical, and Quality support. The role involves working with clients to develop quality systems, writing technical documents, and ensuring compliance with regulatory... 
    Remote job
    Hourly pay
    Part time
    Flexible hours

    Prime Path Medtech™

    New York, NY
    2 days ago
  •  ...Trust Center deep-dive, and a customer who wants to see SOC 2 + ISO 27001 + ISO 42001 evidence before signing. Today this work is...  ...Ideally, you have DevOps chops. We'd love someone who's lived on the engineering side too — comfortable in CI/CD, cloud infra (AWS/GCP), IaC (... 

    Arist

    New York, NY
    15 hours ago
  •  ...An exciting opportunity for a Quality/System Engineer to join a leading organisation in the medical device industry. Based in the area served...  ...relevant standards, including ISO 13485:2016, 21 CFR Part 820,...  ...develop and implement robust design control processes for new and... 
    Worldwide

    Hyper Recruitment Solutions Ltd

    New York, NY
    1 day ago
  • $100k - $110k

     ...Supplier Quality Engineer, Dover, NJ area The Quality Engineer is a key...  ...Product Introduction (NPI), design transfers, and validation of...  ...documentation. Ensure compliance with ISO 9001, AS9100, and customer-...  ..., defense, automotive, medical device, or other highly regulated... 

    GCR Professional Services

    New York, NY
    4 days ago
  • $300 per month

    Innolitics builds AI/ML software for medical devices — the kind that detects ear...  ...radiation therapy. 60+ FDA clearances. We're a remote-...  ...firm (since 2012) that does engineering, regulatory, and...  ...quantitative field. You'll design biostatistical plans for AI... 
    Remote work
    Flexible hours

    Built with Django

    New York, NY
    2 days ago
  • A leading tech company in New York is hiring a Product Test Engineer to ensure the quality and performance of web and software products. The role involves designing and executing test strategies, performing various testing types, and collaborating with cross-functional... 

    OVA.Work

    New York, NY
    2 days ago
  • Quality Engineer - Medical Device Industry Job Summary We are seeking a skilled Quality Engineer with...  ...will have hands‑on experience with FDA regulations, ISO standards, CAPA, investigations, and...  ...Strong understanding of Design Controls and Risk Management principles... 

    Novozen Healthcare LLC

    New York, NY
    2 days ago
  • $100k - $160k

     ...markets hemostatic medical devices utilizing the company...  ...Medical Device R&D Engineer is responsible for leading the design and development activities...  ...compliance with all quality and regulatory...  ...activities adhere to FDA Quality System Regulations and ISO 13485 design control... 
    Full time
    Temporary work
    Part time
    Apprenticeship
    Work experience placement
    Local area

    Cresilon, Inc.

    New York, NY
    10 days ago
  •  ...experienced Product Security Engineer to embed security deeply into how Gecko designs, builds, deploys, and...  ...with a focus on signal quality and developer adoption...  ...compliance frameworks (ISO 27001, SOC 2, NIST 800‑5...  ...neutral parental leave, full medical, dental, and vision... 
    Work at office
    Local area
    Work from home
    Flexible hours

    Gecko Robotics Inc

    New York, NY
    15 hours ago
  •  ...world’s largest device manufacturing companies...  ...an Automation Engineer to support UV-C...  ...Responsibilities Design, implement, and optimize...  ...to drive quality, efficiency, and...  ...innovation across medical device production...  ...sensors. Knowledge of FDA, GMP, or ISO standards.... 
    Full time
    Contract work

    Medasource

    New York, NY
    14 hours ago
  •  ...experienced Senior Software Engineer - Test Infrastructure...  ...products from design into volume manufacturing...  ...reliability tests for Fort devices, manually or automatically...  ...designs to improve quality and manufacturability....  ...standards like IEC 61508 and ISO 26262. Qualifications... 
    Remote work

    FORT Robotics

    New York, NY
    2 days ago
  • Balda-C-Brewer is seeking an Engineering and Program Management professional in New York, NY. Responsibilities include project launch and integration, customer relationship management, and improving operational efficiencies in the manufacturing process. The ideal candidate... 

    Balda-C-Brewer

    New York, NY
    2 days ago
  •  ...Vice President of Quality About the Company...  ...to lead the ISO 13485 certification...  ...) integrated with engineering tools and workflows...  ...certification roadmap, designing and building the...  ...experience in medical devices, with a strong emphasis...  .... A background in FDA inspections and... 

    Confidential

    New York, NY
    4 days ago
  • $200k - $300k

     ...needs. Responsibilities Manage and lead a team of security GRC engineers Perform internal and external security control assessments...  ...standards‑based security frameworks such as CIS, NIST‑CSF, FedRAMP, or ISO Data analysis skills leveraging SQL, Elastic, OSQuery, and... 
    Work at office
    Local area
    Immediate start
    Worldwide

    Hudson River Trading

    New York, NY
    4 days ago
  •  ...Description Organon is recruiting for the position of Co‑Op – Medical Device Engineer to join our world‑class technical operations team. This...  ...Technical Operations Engineers to execute device test methods for design verification starting from method development through the... 
    Fixed term contract
    Internship
    Relocation
    Visa sponsorship
    Shift work

    Organon

    New York, NY
    14 hours ago
  • $90k - $120k

    Quality Engineer - Automotive - Yonkers, NY Join to apply for the Quality Engineer - Automotive...  ..., and ensure compliance with ISO/TS 16949 and customer-specific requirements...  ...Serving industries such as automotive, medical devices, electronics, and aerospace, my client... 
    Local area

    Michael Page

    New York, NY
    2 days ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to Design Quality Engineer - Medical Devices (FDA/ISO). Be the first to apply!