- Philips (Reedsville, PA)
- …the right fit if:** + You've acquired 5+ years of experience in the medical device regulatory affairs and/or quality assurance field. Experience authoring ... Tech Files required. + Your skills include knowledge of quality system requirements and FDA and/or International product approval...won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work… more
- Bayer (Indianola, PA)
- …you will be responsible to design and develop software code for medical device development to deliver a high- quality product that meets or exceeds customer ... Software Engineering Department. As a co-op, you will gain valuable experience in medical device development as well as exposure to a wide range of technologies… more
- Medtronic (Pittsburgh, PA)
- …knowledge of surgical instrumentation. Commitment to upholding the highest standards of safety and quality in medical device reprocessing. + This position is ... + Strong understanding of regulatory requirements and industry standards governing medical device reprocessing. + Excellent communication, interpersonal, and… 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
- ZOLL Medical Corporation (Pittsburgh, PA)
- … devices in domestic and international markets. + Post-market surveillance and medical device reporting in domestic and international markets + Responsible ... innovative technologies that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide to diagnose and… more
- ZOLL Medical Corporation (Pittsburgh, PA)
- …innovative technologies that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide to diagnose and ... (https://cardiacdiagnostics.zoll.com/products/heart-failure-arrhythmia-management-system/) (Heart Failure Management system) is a non-invasive, patch-based device that monitors pulmonary fluid levels and has been… more
- Merck (West Point, PA)
- …and Skills: . **Manufacturing** - Injection Molding and Automated Assembly of Medical Device Components. Final Assembly and Packaging of Combination Products. ... Vaccine Products. Our team works with a "Safety First, Quality Always" mindset. As the primary point of contact...development and manufacturing for MDCP (21 CFR Part 4, Medical Device Reporting, ISO 13485:2016, EU … more
- Envista Holdings Corporation (Quakertown, PA)
- …regulatory and quality backgrounds that work collaboratively in the fast-paced medical device field. A friendly and open atmosphere helps to foster ... problem-solving and cooperation. + Experience and working knowledge of electrical medical device manufacturing (preferred). + Experience with SAP is… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …degree and 15+ years of experience in a FDA regulated pharmaceutical and/or medical device industry environment + Strong knowledge of current global Good ... an experienced and dynamic Executive Director of R&D Global Quality to join our team. This pivotal role will...Previous experience of working in the global pharmaceutical and medical device industry. + Experience working with… more
- PCI Pharma Services (Philadelphia, PA)
- …requiring systemic solutions + Ensure compliance with FDA regulations, ISO 13485, Medical Device Directive, and other applicable standards and regulations ... to pioneer and shape the future of PCI. The ** Quality Systems Manager** is responsible for overseeing and maintaining... management systems and regulatory requirements (FDA, ISO 13485, Medical Device Directive) + Strong knowledge of… more