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
$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$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- 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
- ...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
- 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
- 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...
$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 timeContract workSummer workWork at officeRemote workNight shiftAfternoon shift- 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 jobWork at office
- 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 workFor contractorsSelf employmentFreelanceRemote workWorldwideFlexible hours
$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 wageWork experience placementLocal areaWorldwide- 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
- 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 areaMonday to FridayShift work
- ...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...
$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...H1bVisa sponsorshipFlexible hours$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 jobHourly payPart timeFlexible hours- ...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 (...
- ...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
$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...$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 workFlexible hours- 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...
- 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...
$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 timeTemporary workPart timeApprenticeshipWork experience placementLocal area- ...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 officeLocal areaWork from homeFlexible hours
- ...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 timeContract work
- ...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
- 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...
- ...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...
$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 officeLocal areaImmediate startWorldwide- ...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 contractInternshipRelocationVisa sponsorshipShift work
$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
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