- 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 ... Administration ( FDA ) regulations, ISO 9001, ISO 13485:2003, Medical Device Directive (MOD), the Canadian ...Experience: 6 to 8 years of experience in a Quality Assurance role for medical device… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …product registrations + Preferred experience in negotiating with regulatory authority personnel (eg FDA , Notified Bodies) in medical device and in vitro ... in further launch activities. The ideal candidate will have medical device and in vitro diagnostic experience...product information, and questionnaires requested by customers. + Ensure FDA device listings and facility registrations are… more
- embecta (Parsippany, NJ)
- …is a critical role within embecta, a global leader in medical device manufacturing. This position ensures that all quality systems and operations comply ... with internal standards and regulatory requirements, including FDA and ISO standards. The Quality Compliance...quality compliance or a related role within the Medical Device or Pharmaceutical manufacturing industry. +… more
- Integra LifeSciences (Plainsboro, NJ)
- …guidelines: US Food and Drug Administration ( FDA ) regulations, ISO 9001, ISO 13485, Medical Device Directive (MOD), the Canadian Medical Device ... + Experience: 3 to 6 years of experience in a Quality Assurance role for medical device or pharmaceutical manufacturing. + Demonstrates knowledge of… more
- Integra LifeSciences (Plainsboro, NJ)
- …overall corporate policies, FDA regulations, ISO 9001, ISO 13485, the medical device directive, and the other applicable regulatory agencies. Expectations ... patient outcomes and set new standards of care. The ** Quality Inspector I** will be responsible for performing ...clearance, in-process, and finished goods inspections in pharmaceutical or medical device industry. + QA experience in… more
- Integra LifeSciences (Plainsboro, NJ)
- …overall corporate policies, FDA regulations, ISO 9001, ISO 13485, the medical device directive, and the other applicable regulatory agencies. Expectations ... patient outcomes and set new standards of care. The ** Quality Inspector I** will be responsible for performing ...clearance, in-process, and finished goods inspections in pharmaceutical or medical device industry. + QA experience in… more
- Integra LifeSciences (Plainsboro, NJ)
- …overall corporate policies, FDA regulations, ISO 9001, ISO 13485, the medical device directive, and the other applicable regulatory agencies. Expectations ... patient outcomes and set new standards of care. The ** Quality Inspector I** will be responsible for performing ...clearance, in-process, and finished goods inspections in pharmaceutical or medical device industry. * QA experience in… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …product quality and safety **Skills** + **Regulatory Knowledge:** Extensive understanding of FDA medical device regulations (21 CFR Part 820), ISO ... scatter diagrams). + **Risk Management:** Experience applying risk assessment methodologies to medical device quality systems. + **Auditing:** Demonstrated… more
- J&J Family of Companies (Raritan, NJ)
- …robust GxP Quality Management System of a diverse portfolio of drug and medical device health products and services. This individual serves as the clinical ... health for humanity. Learn more at https://www.jnj.com **Job Function:** Quality **Job Sub** **Function:** Clinical Quality **Job...field and/or equivalent time and experience in a related medical device R&D area + Good understanding… more
- ManpowerGroup (Wayne, NJ)
- …Wayne, NJ **Pay Rate:** $50 per hour Our client, a leading medical device company, is seeking a ** Quality Engineer II** to join their Product Development ... in Quality or Engineering, preferably in the medical device or pharmaceutical industry. + Experience...medical devices is a plus. + Knowledge of FDA 21 CFR 820, ISO 13485, ISO 14971, EU… more