- Dentsply Sirona (Lancaster, PA)
- … excellence across distribution operations, ensuring alignment with regulatory requirements, corporate standards, and customer expectations. **Key ... + Maintain systems, processes, and documentation to support compliance with FDA , ISO 13485, and other applicable international quality standards.… more
- Omnicell (Cranberry Township, PA)
- …with regulatory standards. **Responsibilities:** + Serve as the primary quality representative in the development of On-premise, Edge, Cloud and SaaS software ... quality support of software development. + Liaise with Regulatory and other Quality departments throughout the...Experience working with medical devices (ie ISO 13485 or FDA regulated) + Expertise in machine learning and generative… more
- Dentsply Sirona (Johnson City, TN)
- …QE, QC, and Post-Market Surveillance teams, overseeing all QMS activities defined in the quality manual. * Ensure compliance with FDA , ISO 13485, MDSAP, EU MDR ... CAPA process, risk management activities, and continuous improvement of quality systems. * Promote regulatory awareness and...ISO 11737 series) ✔️ Solid background in ISO 13485, FDA QSR, MDSAP, and EU MDR requirements ✔️ Leadership… more
- Cook Medical (Bloomington, IN)
- …through facilitating, leading, and collaborating with cross function teams including quality , engineering, production, clinical, and regulatory affairs.- Provide ... Quality Management System and its processes to meet FDA 21 CFR 820, ISO 13485, and other applicable... 21 CFR 820, ISO 13485, and other applicable regulatory requirements. Must work and interact effectively and professionally… more
- Integra LifeSciences (Plainsboro, NJ)
- …using electronic document storage. + Minimum of 5+ years' experience in a Quality Systems / Regulatory Compliance environment with a working knowledge preferably ... 13485, the medical device directive, and the other applicable regulatory agencies. **This is for a Weekend Lead, the...the medical device, diagnostics or pharmaceutical industries. Familiarity with FDA regulations and ISO series of quality … more
- Astrix Technology (Irvine, CA)
- …System policies and procedures and applicable external requirements and standards, including FDA , ISO 13485, and other worldwide regulatory agencies pertaining ... (eg MDRs, Vigilance reports, etc.) + Familiarity with medical device complaint files and quality records + Knowledgeable of FDA regulations, 21 CFR part 820 and… more
- Merck (Rahway, NJ)
- …process inefficiencies using operational excellence tools and ensuring alignment with global regulatory requirements (eg, FDA 21 CFR Part 820, ISO 13485, ... teams to improve processes related to device-drug integration. + Partner with Quality and Regulatory teams to ensure compliance with applicable global… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …development and change control, ensuring compliance with US, EU, and other global regulatory requirements. + Author FDA submissions (eg, 510(k), Q-Sub), EU ... compliance. + Serve as a point of contact for FDA , EU Notified Bodies, and other regulatory ...in a scientific, health sciences, or technical discipline (eg, Regulatory Affairs, Quality Assurance, Engineering, Bioengineering, Biology,… more
- West Pharmaceutical Services (Walker, MI)
- Sr Associate, Quality Engineering Requisition ID: 72164 Date: Dec 11, 2025 Location: Walker, MI, US Department: Quality Description: + **_This is an onsite ... area regarding equipment, processes or procedures used. Ensure compliance to regulatory and ISO Management standards. **Essential Duties and Responsibilities** +… more
- Fresenius Medical Center (Lawrence, MA)
- …Understanding of Agile methodology desired but not required. . Thorough understanding of FDA Quality System regulations in relation to software development and ... **PURPOSE AND SCOPE** Act as a Quality Business Partner for Software as a Medical...minimize risk to users and patients as well as regulatory and corporate SOP compliance. . Reviews and approves… more