- Merck & Co. (Rahway, NJ)
- …injection.-- Job descriptionThis position will be responsible for leading and implementing medical device and combination product design controls for both new ... types of engineering plus 10 years of related experienceHas broad knowledge of medical device development, design controls and risk managementLed and managed… more
- Merck & Co. (Rahway, NJ)
- …expertise and knowledge of product and process development in the (bio)pharmaceutical and medical device industries to set tactical and strategic direction on ... programs to ensure delivery of high- quality products, test methods, and robust manufacturing processes for...launch. The ideal candidate will possess extensive knowledge in medical device engineering, particularly in the design,… more
- Merck & Co. (Rahway, NJ)
- …-- Required Experience and Skills: Experience in the pharmaceutical, biotechnology, chemical, medical device , or closely related industry.- Experience in one or ... in compliance with cGMP and regulatory filings. Perform independent quality review and approval of batch records, testing data, and related documents… more
- Merck & Co. (Durham, NC)
- …Experience and Skills: Manufacturing - Injection Molding and Automated Assembly of Medical Device Components. Final Assembly and Packaging of Combination ... 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)
- …product control strategies, statistical analysis, and advanced statistical methods for medical device and combination product engineering within the ... have a background in data science, statistics, and a strong understanding of medical device and combination product regulations and processes.- It is expected… more
- Merck & Co. (Rahway, NJ)
- …robust scientific methodology we collaborate to discover and develop the next medical breakthrough. Our Company's success is backed by ethical integrity, forward ... (PSCS) deliverable which is the development of robust compositions, processes and device / packaging that enable patient centric products for patients. The successful… more
- Merck & Co. (Rahway, NJ)
- …cross-functional impact, including drug device /combination products and software as medical device platforms.- Reviews and resolves issues that span diverse ... in the US and globally to execute efficiently on regulatory obligations, compliance requirements and company strategy.Providing quality advice to stakeholders… more
- Merck & Co. (Rahway, NJ)
- …to commercialization. -Our development teams ensure robust composition, primary packaging/ device , and process selection through deep fundamental understanding and ... for CMC.- Strong understanding of integration and partnering with Quality , Regulatory, Operations, Non-clinical, Clinical, and other functional areas.Demonstrated… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Experience10+ years of experience in GxP-regulated IT system implementation, validation, and compliance in pharma/biotech/ medical device industry - Required ... ensuring alignment with the Global Digital Transformation (DX) strategy, regulatory compliance framework, and overall quality assurance standards. This role… more
- Repligen (Rancho Dominguez, CA)
- …fluency in English (reading and writing) is required.3+ years of medical device assembly experience.Experience working with hand tools, power ... member in whatever capacity and job function is required to deliver a quality product to our customer in a timely fashion.ResponsibilitiesPerform manual assembly of… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …3+ years of pertinent experience. Solid understanding of QA, Regulatory, and Quality Compliance in the medical device industry. Exhibit strong oral and ... Become a **maker of possible** with us. The **Staff Quality Risk Management Engineer** is responsible for planning, coordination...management. Plan and execute the management of risk for medical device projects to ensure that risks… more
- Medtronic (Minneapolis, MN)
- …embedded security of regulated or safety critical devices. + Experience in Quality / Compliance and/or Audit with medical device requirements (eg, MDSAP, ... Compliance Audit Specialist focus will be primarily medical device software, product security, and risk...Bachelor's degree with 7+ years of work experience in Quality or regulated industry OR Advanced degree with 5+… more
- West Pharmaceutical Services (Walker, MI)
- …matter expert in the development and execution of Quality Management System Compliance to Medical Device and Pharmaceutical regulations for Combination ... or industrial engineering **Work Experience** + Minimum 10+ years in medical device /pharmaceutical manufacturing, quality assurance, regulatory affairs,… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Gilead and CMO APQRs for commercial products. + Accountable for medical device / combination product quality compliance : engage/liaise with medical ... in development and/or commercial programs. **Job Functions:** + Accountable for end-to-end quality compliance of the assigned product/program, which include but… more
- Adecco US, Inc. (Cupertino, CA)
- …**Labelling/ Quality Compliance Specialist** to support global medical device labelling operations within a high-performance technology environment. ... and innovation in recruiting for a Labelling Specialist / Quality Compliance Specialist III in Cupertino, CA....creation and maintenance of Instructions for Use (IFU) in compliance with global medical device … more
- Abbott (Alameda, CA)
- …-related field. + 5+ years of experience in quality assurance or regulatory compliance in the medical device industry. + Strong knowledge of ISO ... medicines. Our 114,000 colleagues serve people in more than 160 countries. **Sr. Quality Compliance Specialist** **Working at Abbott** At Abbott, you can do… more
- Abbott (Barceloneta, PR)
- …in engineering discipline + 2 years of experience in Quality and/or Compliance , preferably in medical device industry **Preferred Qualifications** + ... spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues… more
- Wolters Kluwer (Chicago, IL)
- …a broad portfolio of on-market medical devices including Software as a Medical Device (SaMD) within the Health Division in Wolters Kluwer. Important ... regulations, 510(k)s, labeling and promotional materials, 21 CFR 820, global medical device registration, technical writing, and external standards.… more
- Regeneron Pharmaceuticals (East Greenbush, NY)
- We are currently looking to fill a Medical Device Quality Engineer position. This position will provide Quality Assurance oversight and ensure ... compliance in the support of combination device development life cycles. In this role, a typical...in combination device or medical device industry for each level: + Associate Quality… more
- Integra LifeSciences (Plainsboro, NJ)
- …treatment pathways to advance patient outcomes and set new standards of care. The **Sr.** ** Quality Engineer - Medical Device / Pharma** will provide Plant ... Quality compliance support for the following Quality tasks...Experience: 6 to 8 years of experience in a Quality Assurance role for medical device… more
