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MannKind
9 views 3 weeks ago

Associate Manager, Supplier Quality Assurance & Audits

Open 20d North AmericaContract
United States

MannKind, a biopharmaceutical company, is hiring an Associate Manager of QA Compliance in Danbury, CT to plan, execute, and report internal, supplier, and GCP/PV quality audits, manage CAPAs and the approved vendor list, and support inspection readiness and regulatory interactions. Core focus: GxP/cGMP compliance, ISO 13485, MDSAP, and supplier quality.

GCP Iso 13485
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MannKind
4 views 3 weeks ago

Specialist III, QA Sterile Manufacturing

Open 20d North America
United States

Serves as the primary Quality Assurance representative on the sterile manufacturing floor of a pharmaceutical company, providing real-time GMP oversight of aseptic production, batch record review/approval, deviations, CAPAs, and material status for commercial and clinical sterile products.

Corrective Action Iso 13485 Regulatory Compliance Risk Assessment
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C & J Industries Inc
2 views 3 weeks ago

Sales Representative/Business Development - Injection Molded Plastics - REMOTE

RemoteNorth America
United States

Description C&J Industries is a custom plastic injection molding company serving a diverse range of industries. In-house services include tooling design and production, extensive assembly options and full-service…

Iso 13485 Iso 9001
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HeartFlow
1 views 3 weeks ago

Senior Device Quality Engineer

Open 76d North AmericaSenior 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.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

Heartflow is a medical technology company advancing the diagnosis and management of coronary artery disease, the #1 cause of death worldwide, using cutting-edge technology. The flagship product—an AI-driven,…

Agile AI Cloud Cybersecurity Iso 13485 +3 skills
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HeartFlow
6 views 3 weeks ago

Principal Device Quality Engineer

Open 61d North AmericaPrincipal 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.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

Heartflow is a medical technology company advancing the diagnosis and management of coronary artery disease, the #1 cause of death worldwide, using cutting-edge technology. The flagship product—an AI-driven,…

Agile AI Cloud Cybersecurity Iso 13485 +4 skills
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HeartFlow
9 views 3 weeks ago

Senior Manager, Quality System & Compliance

Open 56d North AmericaSenior 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.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

Heartflow is a medical technology company advancing the diagnosis and management of coronary artery disease, the #1 cause of death worldwide, using cutting-edge technology. The flagship product—an AI-driven,…

AI Cloud Cybersecurity Iso 13485 Machine Learning +1 skills
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Intuitive Surgical
4 views 3 weeks ago

Continuous Improvement Quality Engineer (CIQE)

Open 19d HybridNorth America 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.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

Primary Function of the Position Ensure that quality systems, products, and manufacturing processes comply with quality standards by supporting and driving improvements in the organization and in accordance with…

Accessibility Corrective Action Iso 13485 Personal Protective Equipment (PPE) Process Improvement +2 skills
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Cordis
3 weeks ago

Principal Sustaining Quality Engineer (Post-Market)

RemoteNorth AmericaPrincipal
United States

Overview Selution, in partnership with Cordis, specializes in the development of groundbreaking technology and commercialization of advanced drug-device combination products for the treatment of coronary and peripheral…

Iso 13485 Regulatory Compliance Technical Writing
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Intuitive Surgical
5 views 3 weeks ago

Quality Engineer 3

Open 19d LATAM 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.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.
Mexico

Primary Function of Position: The Quality Assurance department is devoted to assuring safe, reliable, and effective products that exceed patient, surgeon, and hospital expectations. The department plays a vital role in…

Iso 13485 Root Cause Analysis
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Nova Biomedical
5 views 3 weeks ago

Program Manager Product Development

Open 20d North 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

Program Manager who owns end-to-end delivery of new product development and product sustaining programs for Nova Biomedical's medical device/IVD instrumentation — running the stage gate process, holding cross-functional teams (R&D, Quality, Regulatory, Operations, etc.) to committed dates, managing budgets, risk registers, and executive status reporting. Core expertise: stage gate medical device d

Cybersecurity Iso 13485 PMP Program Management
190K – 270K $
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Neuronetics
3 views 3 weeks ago

Field Service Engineer

Open 20d North AmericaFull-time
United States

Position Overview: The Field Service Engineer is responsible for administrative duties that ensure all technical customer service requirements are satisfied. This position is critical to customer support and reports to…

Iso 13485 Root Cause Analysis Technical Writing
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University Health Network
3 views 3 weeks ago

Senior Manufacturing Engineer

Open 20d North AmericaFull-timeSenior Canada LMIA employer — This employer was issued a positive Labour Market Impact Assessment by Employment and Social Development Canada in the last four quarters, through the High Wage, Global Talent or Permanent Resident streams. The approval belongs to the employer and is not a commitment to sponsor this role.
Canada

Union: Non-Union Number of vacancies: 1 New or Replacement Position: New Site: 2400 Skymark Ave unit 3, Mississauga, Ontario L4W 5K5, Canada Department: Manufacturing Reports to: Vice President of Manufacturing and…

Assembly CAD ERP Iso 13485 Risk Assessment +2 skills
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Nova Biomedical
6 views 3 weeks ago

Principal Talent Acquisition Partner, EMEA

Open 20d Europe, UKPrincipal 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.

Nova Biomedical: One Global Brand. One Vision. Together under one name. Advanced Instruments and Nova Biomedical are now united under one brand, Nova Biomedical , marking a major milestone in our journey to deliver…

AI Analytics Candidate Experience Full Cycle Recruiting Iso 13485 +2 skills
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Etac
3 weeks ago

Kvalitetstekniker

Open 15d Europe
Sweden

I takt med att Etac fortsätter att växa stärker vi nu vårt kvalitetsarbete i Anderstorp. Vi söker därför en Kvalitetstekniker som vill ta en central roll i vårt operativa kvalitetsarbete. Här får du möjlighet att…

FMEA Iso 13485 Iso 9001
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Clinical Ink
39 views 3 weeks ago

AI Engineer

Open 20d RemoteNorth 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

Clinical Ink is hiring an AI Engineer for its US-based Digital Health Technology team to build end-to-end integrations for connected medical devices (mobile SDKs, vendor APIs, ingestion pipelines) and an AI layer of LLM/agentic tooling that accelerates future integrations. Core stack: Python, Docker/Kubernetes (EKS), AWS, PostgreSQL, GitLab CI/ArgoCD.

Agentic AI AI Analytics Android API +34 skills
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TOP CLEAN INJECTION
3 weeks ago

Technicien SAV (H/F)

EuropeFull-time
France

Rejoignez Top Clean Packaging, expert de la plasturgie et acteur reconnu dans la conception et la fabrication de dispositifs médicaux et de solutions de packaging ! Vous intégrerez notre site de production dédié aux…

Iso 13485
Career Wise
7 views 3 weeks ago

Assistant Quality Manager

Open 21d APAC
Malaysia

Job Responsibilities Assist the Quality Manager in overseeing the company's quality management system and daily quality-control activities. Lead and supervise the Quality Assurance and Quality Control teams to ensure…

FMEA Iso 13485 Iso 9001 Root Cause Analysis
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OSI Electronics
3 views 3 weeks ago

QA Engineer

On-siteAPAC
Indonesia

Overview For over 35 years, OSI Electronics has provided Manufacturing Solutions of the highest quality,reliability, andcustomersupport.Wespecialize in customized Manufacturing Solutions with the portfolioof services,…

Agile Assembly Corrective Action Iso 13485 ISO 14001 +5 skills
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Biomed Global
6 views 3 weeks ago

Supply Chain – Warehouse & Logistics - Manager

Open 21d APACContract
Malaysia

Purpose of Job: To lead end-to-end warehouse and logistics operations, ensuring operational efficiency, inventory accuracy, cost control, regulatory compliance, and timely delivery, while driving continuous improvement…

Automation ERP Iso 13485 Process Improvement Regulatory Compliance +1 skills
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Natus Sensory
18 views 3 weeks ago

Senior AI Engineer – Agentic Software Development

Open 20d EuropeSenior
Denmark

Job Function: Engineering | Job Family: Software Engineering The opportunity Otometrics, a division of Natus Sensory, builds audiology devices that help clinicians make better decisions for their patients. Our R&D…

AI Ai Enablement CI/CD C# .NET +4 skills
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