- Integra LifeSciences (Princeton, NJ)
- …experience is required. + Experience in highly regulated industries required, medical device and/or pharmaceutical preferred, including material remediation ... experience. + Experience in implementing remediation programs, and working with compliance frameworks such as FDA, ISO 13485, and EU MDR is required + Strong… more
- Kelly Services (Irvine, CA)
- …least 5 years of experience in a Quality , Manufacturing or Engineering function in medical device industry * At least 5 years of experience in a Quality ... , Manufacturing or Engineering function in medical device industry * Experience with MDSAP Audits, health authorities and notified bodies * Working knowledge of … more
- ZOLL Medical Corporation (Pittsburgh, PA)
- …to understand the appropriate legal and regulatory requirements in the areas of medical device operations and to establish robust processes and controls to ... discipline. required + Experience in an FDA regulated Class III electrical medical device manufacturing environment preferred.preferred and + Experienced in… more
- Oura (San Francisco, CA)
- …Regulation (QSR) and Good Manufacturing Practices (GMPs), as well as post-market compliance , including Medical Device Reporting (MDR), product recalls, ... local co-working locations. The AGC, Senior Director of Regulatory Compliance & Privacy will provide strategic legal guidance on...wearable devices and related software, including Software as a Medical Device (SaMD), Software in a … more
- ZOLL Medical Corporation (Pawtucket, RI)
- …discipline * 1 - 3 years related experience in a regulated environment, preferably medical device * Proficient at problem solving * Excellent verbal & written ... resolution of product nonconformities * Adhere to and ensure compliance with Quality System SOPs, work instructions,...3+ years related experience in a regulated environment, preferably medical device * Proficient at problem solving*… more
- Globus Medical, Inc. (Audubon, PA)
- …improvement, or manufacturing operations. + Strong understanding of medical device manufacturing, regulatory compliance , and quality assurance ... sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our...and fast-paced team dedicated to innovation and efficiency in medical device development. + Make a meaningful… more
- GRAIL (Durham, NC)
- … assurance, diagnostics, and/or regulatory compliance within the diagnostics, or medical device field. + Experience supporting regulatory inspections such as ... as they relate to clinical trial conduct + Understanding of appropriate global medical device /IVD requirements, such as: ICH E6 (GCP), European Union (ISO… more
- Terumo Medical Corporation (Elkton, MD)
- …or similar. + Requires six to ten years increasing responsibility and experience in a medical device quality assurance environment. + Prefer one to two years ... develops, manufactures, and markets a complete, solutions-based portfolio of high- quality medical devices used in a broad...of Tokyo-based Terumo Corporation; one of the world's leading medical device manufacturers with $6+ billion in… more
- Terumo Neuro (Aliso Viejo, CA)
- …standards, good clinical practices, and guidelines applicable to the medical device industry to contribute to overall quality and regulatory compliance ... standards, good clinical practices, and guidelines applicable to the medical device industry. + Identify gaps and...Quality by Design (QbD). 6. Strong knowledge of compliance risks and quality controls. 7. Experience… more
- ZOLL Medical Corporation (Pawtucket, RI)
- …to be a part of ZOLL! Job Summary In-Process and Final Inspection of all medical device products manufactured and distributed by ZOLL Medical Pawtucket to ... and records quality testing information as part of a DHR ( Device History Record). * Initiates DMR's (Discrepant Material Report) for nonconforming material. *… more
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