- System One (Piscataway, NJ)
- …support laboratory investigations, deviations, OOS results, and CAPAs + Participate in Quality Events and regulatory inspections (eg, PAI) + Collaborate with ... Job Title: Quality Control Analyst II/III Location: Piscataway, NJ (Onsite:...and biosimilar products. Candidates must bring strong GMP and regulatory knowledge, with expertise in protein chemistry and analytical… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …education and relevant experience. **Knowledge and Skills** + Applied knowledge of the FDA medical device quality system regulations and international quality ... **Job Description Summary** The Sr. Quality Engineer is accountable for supporting new product...Unit policies, while meeting all design control and other regulatory requirements. **Job Description** We are **the makers of… more
- F & S Fresh Foods (Vineland, NJ)
- Supply Chain Quality Manager Vineland, NJ (http://maps.google.com/maps?q=Vineland+NJ+USA+08362) * Quality Assurance Job Type Full-time Description Join the Fresh ... in Vineland, NJ, or Riverside, CA. As ourSupply Chain Quality Manager, you'll be the guardian of ingredient and...a strong, compliant, and resilient supply chain that meets regulatory requirements, customer expectations, and our own high internal… more
- Integra LifeSciences (Plainsboro, NJ)
- …Medical Device Directives, Canadian Medical Device Regulations, and other applicable regulatory agencies. Experience with assessing quality suppliers and ... patient outcomes and set new standards of care. The ** Quality Compliance Specialist** will provide quality compliance...and internal Standard Operating Procedures + Provide support in FDA inspections, ISO audits and customer audits at the… more
- Otsuka America Pharmaceutical Inc. (Princeton, NJ)
- …planning of regulatory interactions and Provides tables and listings for FDA meeting briefing packages. + Support statistical needs for market access and ... statistical expertise/input in the drug development including clinical development plan and regulatory submission strategy. This is a strategic and critical role in… more
- Oracle (Trenton, NJ)
- …Cloud SCM, Manufacturing, Quality , and ERP** integrations. + Knowledge of ** regulatory compliance processes** ( FDA , ISO, cGMP) and quality documentation ... initiatives, spanning **Innovation Management, Product Development, Product Hub, and Quality ** modules. You'll collaborate with cross-functional business teams (Manufacturing,… more
- Oracle (Trenton, NJ)
- …designs are aligned with device-level safety, performance, and compliance needs. + Regulatory Compliance & Quality Alignment + Ensure adherence to medical ... and IEC 82304 (health software product safety and effectiveness). + Embed regulatory and quality requirements into the architecture and development lifecycle,… more
- Oracle (Trenton, NJ)
- **Job Description** Oracle Health is transforming its development and regulatory processes to meet heightened FDA , MDR, and ISO 14155 standards and address ... clinical oversight across Oracle Health, partnering with product development, engineering, quality , and regulatory functions to align clinical best practices… more
- Bausch + Lomb (Bridgewater, NJ)
- …to serve as Vice President, Global IT Lead for Manufacturing, Supply Chain, Quality , and R&D. This leader will be accountable for designing and executing an ... VP will partner with senior business leaders across Operations, Supply Chain, Quality , and R&D to modernize our technology landscape, drive efficiencies, and… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …and managing cross-functional teams. + Strong understanding of R&D functions and the regulatory landscape (GxP, ICH, FDA , EMA, etc.). + Proven ability to ... The Director, Quality & Compliance Training, is a senior leader...leader within the Learning Center of Excellence under Global Quality . This role is responsible for developing and executing… more