- 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
- Merck (Rahway, NJ)
- …of US and global medical device and healthcare regulations, including FDA combination products cGMP, Quality System Regulation, FDA Human Factors ... expertise and knowledge of product and process development in the (bio)pharmaceutical and medical device industries to set tactical and strategic direction on… more
- Merck (Rahway, NJ)
- …of US and global medical device and healthcare regulations, including FDA combination products cGMP, Quality System Regulation, FDA Human Factors ... description** This position will be responsible for leading and implementing medical device and combination product design controls for both new products and… 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)
- …or equivalent (Preferred) + Minimum 10 years of experience work experience in the Quality organization of a Medical Device and/or pharmaceutical company. ... responsible for the implementation and oversight of the BD Quality Audit program. In this role, she/he is responsible... Audits to assure compliance with domestic and international medical device standards and regulations, local procedures,… more