- 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
- Merck & Co. (Rahway, NJ)
- …operational or technical experience within the pharmaceutical, biopharmaceutical, vaccine, or medical device industryExpert knowledge of GMP requirements for ... Oversee the Compliance, Remediation, and Support (CRS) team within Global Quality Compliance Support. Provide compliance leadership and direction to our company… 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)
- …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)
- …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)
- …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
