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Ortho-Clinical Diagnostics, Inc.
5 views 2 weeks ago

Quality Lead Design Transfer & Tech Transfer Strategy

Open 15d On-siteNorth AmericaContractLead H-1B sponsor history — This employer has had H-1B petitions approved by USCIS in the last five fiscal years, per the USCIS H-1B Employer Data Hub. The approval belongs to the employer and is not a commitment to sponsor this role.
United States
Rochester

A senior quality engineer role at QuidelOrtho (in vitro diagnostics) acting as the primary Quality partner for assay design transfer and technology transfer strategy — defining compliant transfer plans, interpreting regulations (ISO 13485, IVDR, FDA QSR), supporting audits, and mentoring engineers. Onsite in Rochester, NY or Raritan.

Iso 13485 Process Improvement Regulatory Compliance Six Sigma
135K – 175K $
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Hims & Hers
7 views 2 weeks ago

Sr. Engineer, Design Quality Assurance

Open 15d On-siteNorth AmericaFull-timeSenior
United States
Minnetonka

A Senior Design Assurance Engineer at Hims & Hers supports sustaining and new product development for Class II medical devices, ensuring effective transfer into manufacturing. Day to day they handle risk management, design controls, FMEAs, design history files, and verification/validation using quality tools and ISO standards.

Corrective Action Iso 13485 Personal Protective Equipment (PPE) Usability Testing
140K – 160K $
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ООО РАПИД БИО
2 views 2 weeks ago

Старший бухгалтер

Open 15d CISSenior
Russia
Москва

Компания “Рапид Био” занимается разработкой экспресс тестов в России. Цель — создание доступной и точной экспресс диагностики для здравоохранения. Лаборатория и производство «Рапид Био» расположены в технопарке…

1C Iso 13485
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Natus Medical
5 views 2 weeks ago

Supplier Quality Engineer

HybridNorth America H-1B sponsor history — This employer has had H-1B petitions approved by USCIS in the last five fiscal years, per the USCIS H-1B Employer Data Hub. The approval belongs to the employer and is not a commitment to sponsor this role.
United States
Middleton, WI, Madison, WI

Location: Middleton, WI (Hybrid Role) About the Role We're looking for an experienced Supplier Quality Engineer to help ensure the quality and reliability of the parts, materials, and services that go into our…

Corrective Action Iso 13485
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3000 Merative US L.P.
3 views 2 weeks ago

Sr Specialist, Product Safety Risk Management

Open 15d RemoteSenior

The Senior Specialist, Product Safety Risk Management is responsible for supporting the safety of regulated and non-regulated medical imaging software devices through ownership and application of ISO 14971-compliant…

Agile Cloud Corrective Action Cybersecurity Hazard Identification +3 skills
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Polysciences, Inc.
4 views 2 weeks ago

Analytical Chemist I/II

Open 15d North AmericaFull-time
United States
Warrington, PA 18976

Analytical Chemist I / II Polysciences, Inc. | Warrington, PA | Full-Time | Research & Development Advance Innovation Through Analytical Chemistry Polysciences, Inc. is a specialty chemical manufacturer headquartered…

Acceptance Criteria Iso 13485 Iso 9001 LIMS Process Improvement
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MPE
4 views 2 weeks ago

Senior Manufacturing Engineer - Assembly

Open 15d North AmericaSenior
United States
Milwaukee, WI

Job Summary Manufacturing Engineering - Assembly is responsible for sustaining and continuously improving released assembly and sub-assembly manufacturing processes for electromechanical products. This includes…

Assembly Automation CAD Corrective Action Iso 13485 +3 skills
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MPE
3 views 2 weeks ago

Senior Process Engineer - Assembly

Open 15d North AmericaSenior
United States
Milwaukee, WI

Job Summary Process Engineering is responsible for developing new assembly and sub-assembly manufacturing processes for electromechanical products, from manufacturability review and quoting support through first…

Assembly CAD Corrective Action Iso 13485 Iso 9001 +3 skills
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3shape.teamtailor.com
7 views 2 weeks ago

Post Market Surveillance Manager

Open 15d Europe
Denmark
København

Are you ready to pursue your career within disruptive MedTech working with 3D scanners and software medical devices in a global setting? Then 3Shape offers a unique opportunity to work as Post-Market Surveillance…

AI CAD Corrective Action Iso 13485
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3Shape
5 views 2 weeks ago

Post Market Surveillance Manager

Open 15d Europe
Denmark
København

Are you ready to pursue your career within disruptive MedTech working with 3D scanners and software medical devices in a global setting? Then 3Shape offers a unique opportunity to work as Post-Market Surveillance…

AI CAD Corrective Action Iso 13485
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Resonetics
9 views 2 weeks ago

Quality Engineer I

Open 59d North AmericaJunior H-1B sponsor history — This employer has had H-1B petitions approved by USCIS in the last five fiscal years, per the USCIS H-1B Employer Data Hub. The approval belongs to the employer and is not a commitment to sponsor this role.
United States
Hutchinson, MN

Overview Resonetics is a global leader in advanced engineering, prototyping, product development, and micro manufacturing, driving innovation in the medical device industry. With rapid expansion across all our…

Corrective Action Iso 13485 Minitab Prototyping Six Sigma +1 skills
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Aspen Surgical
2 views 2 weeks ago

Design Engineer (Sustaining)

North America
United States
Caledonia, MI

Summary The Design Engineer is responsible for Designing medical devices to support the growth, cost profile, and business continuity of Aspen Surgical products while working in a collaborative team environment. In…

FMEA Iso 13485 Minitab SolidWorks
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Halcyon Knights
8 views 2 weeks ago

Embedded Software Engineer

Open 15d HybridAPAC
Australia
Melbourne VIC

Senior Embedded Software Engineer – C/C++ | Linux | MedTech An innovative, venture-backed Australian MedTech company is developing next-generation monitoring technology designed to improve clinical decision-making and…

C++ Data Science Embedded Software Embedded Systems Firmware +5 skills
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Boston Scientific
3 views 2 weeks ago

Engineer II, Software Quality Assurance

HybridAPACMiddle Licensed UK sponsor — This employer appears on the GOV.UK register of licensed sponsors for the Skilled Worker and related work routes. The licence belongs to the employer and is not a commitment to sponsor this role.Ireland permit employer — This employer was issued Irish employment permits this year or in the two years before, per the Department of Enterprise, Tourism and Employment. The permits belong to the employer and are not a commitment to sponsor this role.
India
Gurgaon IN-HR, N/A

Additional Locations: N/A Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in…

Agile Cybersecurity Iso 13485 Jira Risk Assessment +2 skills
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SaniSure
3 views 2 weeks ago

Senior Global Quality Engineer - Sterilization

Open 15d North AmericaContractSenior
United States
Camarillo, CA

About SaniSure SaniSure is a high-growth multinational manufacturer of single-use products and systems used in the production of biological drugs, including cell therapies, gene therapies, and vaccines. With operations…

Corrective Action FMEA Iso 13485 Risk Assessment Root Cause Analysis +2 skills
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SaniSure
3 views 2 weeks ago

Manufacturing Engineer

Open 15d North America
United States
Camarillo, CA

About SaniSure SaniSure is a high-growth multinational manufacturer of single-use products and systems used in the production of biological drugs, including cell therapies, gene therapies, and vaccines. With operations…

CAD Corrective Action Design of Experiments (DOE) Iso 13485 Regulatory Compliance +1 skills
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Riverpoint Medical
3 views 2 weeks ago

Manufacturing Engineer I

Open 15d North AmericaInternshipJunior
United States
Portland, OR

Riverpoint Medical in Northeast Portland is hiring a Manufacturing Engineer I . At Riverpoint you will be part of the process that brings great technology to Medical, Dental and Veterinary markets. We specialize in the…

Assembly CAD Design for Manufacturing (DFM) Iso 13485 Root Cause Analysis +2 skills
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Evergen
6 views 2 weeks ago

Quality Systems Manager

Open 15d RemoteNorth AmericaContract
United States
Alachua, FL

Location: Alachua, FL Annual CIP bonus opportunity of up to $15,000.00 Evergen is a global industry-leading contract development and manufacturing organization (CDMO) in regenerative medicine. As the only regenerative…

Agile Corrective Action Iso 13485 Process Improvement
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GE Healthcare
6 views 2 weeks ago

Senior Clinical Product Manager

Open 15d APACSenior Licensed NL sponsor — This employer appears on the IND public register of recognised sponsors for work and highly skilled migrants. The recognition belongs to the employer and is not a commitment to sponsor this role.H-1B sponsor history — This employer has had H-1B petitions approved by USCIS in the last five fiscal years, per the USCIS H-1B Employer Data Hub. The approval belongs to the employer and is not a commitment to sponsor this role.Ireland permit employer — This employer was issued Irish employment permits this year or in the two years before, per the Department of Enterprise, Tourism and Employment. The permits belong to the employer and are not a commitment to sponsor this role.
China
BeiJing

Job Description Summary • Relevant clinical medicine background and software product experience to define clinical product marketing strategy and sync to plan the roadmap for medical imaging digital software platform.…

Acceptance Criteria Agile AI Data Governance Data Quality +4 skills
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cochlear
6 views 2 weeks ago

Customer Software Verification and Validation Engineer

Open 15d APAC
Malaysia
Kuala Lumpur

Change people’s lives and love what you do! Cochlear develops world-leading medical devices that help people hear. As a top 100 medical device company and market-leader in implantable hearing devices, more people…

Agile Appium Atlassian Automation Business Intelligence +14 skills
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