- Merck & Co. (Durham, NC)
- …Experience and Skills: Manufacturing - Injection Molding and Automated Assembly of Medical Device Components. Final Assembly and Packaging of Combination ... and compliance requirements governing development and manufacturing for MDCP (21 CFR Part 4, Medical Device Reporting, ISO 13485:2016, EU Medical Device … more
- Merck & Co. (Rahway, NJ)
- …and ISO 13485:2016 for review of Quality Management System documents for the Quality Manual.Previous experience in Medical Device and/or Medical ... of medical devices or medical device combination products with experience in quality ...Quality Management System/ Purchasing Controls and in managing external partners / suppliers. Current Employees apply HERE Current… more
- Merck & Co. (Rahway, NJ)
- …stability testing according to specifications for all programs including vials, medical device components and combination products.Responsible for performing ... Quality , and Strategy Leads.Support, manage, and coordinate analytical support for vials, medical device release testing in a timely manner following GMP… more
- Tris Pharma (Monmouth Junction, NJ)
- …knowledge or skills needed and/or licenses or certificates preferredCertified Quality Manager, Engineer or AuditorExperience working with drug- device ... has an immediate opening for a SR. Manager or Manager, Quality Management Systems (QMS). Title commensurate with experience.Summary:This position supports, oversees… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …database and data validation programming and/or related work experience in a medical device , biotech, or pharmaceutical company, or similar environment (eg, ... to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class...study teams in a timely manner. Provides oversight for external data validation and quality control process… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …equivalent experience from any of these industries: Pharmaceuticals, biologics, Medical Device , Vaccines, Diagnostics, Generics/ Consumer productsDemonstrated ... diseases and immune disorders. JOB SUMMARYThe Senior Director, Head Medical affairs Quality Assurance in Global RD/PV...One Quality voice as the best trusted quality partner with internal and external stakeholders.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and relevant regulatory requirements. This position has experience working within the medical device and/or pharmaceutical industry across complex disease areas, ... advanced analytical tools and assays. Clinical data management experience in a medical device , pharmaceutical company, or similar environment (eg, CRO);… more
- Merck & Co. (Rahway, NJ)
- …to commercialization. -Our development teams ensure robust composition, primary packaging/ device , and process selection through deep fundamental understanding and ... with organizational goals.Maintain a strong network internally and across the external academic and regulatory community and build collaborations across internal… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …responsible related experience; including hands on related pharmaceutical or medical device /pharmaceutical combination product experience and actual regulatory ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of relevant experience preferredData management and/or related work experience in a medical device or pharmaceutical company, or similar environment (eg, CRO) ... pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …relevant includes clinical or basic research in a Pharmaceutical company, a Medical device /Diagnostic company, Academic Research Organization (ARO) or Contract ... pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and… more
- AbbVie (North Chicago, IL)
- …YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description Purpose: The Manager, Medical Device External Quality is part of ... and Product Quality Assurance group and reports to the Senior Manager, Medical Device External Quality . The role will be based out of Lake… more
- Organon & Co. (Jersey City, NJ)
- …and review of documentation to ensure compliance with applicable Medical Device Regulations and internal Organon requirements. Sr. Quality Engineer ( ... **This position will be the first contact support for external inspection support for Organon LLC and must work...cGMP and quality issues related to pure medical devices and the device constituent of… more
- Sanofi Group (Cambridge, MA)
- …will be responsible for the quality assurance efforts for our Software as Medical Device (SaMD) products, ensuring that they meet the highest standards of ... ensure the safety of all users and patients. **Supplier Quality :** + Manage external suppliers throughout the...sciences. + 4+ years' experience in medical device product development (Design Control) focused on quality… more
- Wolters Kluwer (Chicago, IL)
- …and promotional materials, 21 CFR 820, global medical device registration, technical writing, and external standards. **QUALIFICATIONS** **Education:** ... on-market medical devices including Software as a Medical Device (SaMD) within the Health Division...in existing processes and develop new processes. + Support external and internal audits; represent Quality Assurance… more
- Takeda Pharmaceuticals (Lexington, MA)
- …devices for drug delivery including combination products, solid understanding of polymeric medical device manufacturing processes via molding and assembly, and ... the creation of design control deliverables to comply with medical device and combination device ...External ** **Contacts:** + Collaborate with commercial Product teams, Quality , Mfg, Regulatory, R&D, Clinical, Legal + Work closely… more
- Sanofi Group (Morristown, NJ)
- …and bring hope to patients and their families. The strategic vision of Sanofi's Global Medical Device and Packaging organization is to lead the industry in ... and 10+ years' work experience in combination product or medical device development, or MS/PhD in mechanical,...issues and challenges. + Strong knowledge of the US/EU external device -mediated drug delivery technology innovation eco-system.… more
- West Pharmaceutical Services (Exton, PA)
- Senior Specialist, Regulatory Affairs - Medical Device Requisition ID: 69746 Date: Jun 11, 2025 Location: Exton, Pennsylvania, US Department: Regulatory Affairs ... regulatory requests. **Essential Duties and Responsibilities** + Develop and implement medical device regulatory strategies for West's administration and safety… more
- Regeneron Pharmaceuticals (East Greenbush, NY)
- …development lifecycle of an off the shelf, or an internally designed platform medical device delivery system. + Defines detailed product requirements and ... equivalent combination of education and experience Previous experience in combination product/ medical device development or similar area is required. Experience… more
- Aerotek (Irvine, CA)
- **Cleanroom Operator** + This position is responsible for the production of high- quality medical devices within a manufacturing cell. + Working under close ... test operations on pacemakers, implantable cardioverter defibrillators (ICDs), leads, and related medical device assemblies. + The role requires spending 95% of… more
