- Globus Medical, Inc. (Audubon, PA)
- …we move with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our team is inspired by the ... product development + Create and maintain project plans and FDA complaint Design history Files (DHF) for each project...of tasks while remaining in full compliance with Globus quality system and other applicable regulatory bodies + Design… more
- Geisinger (Danville, PA)
- …Physics Department. Job Duties + Meets and maintains the ACR and Mammography Quality Standards Act (MQSA) requirements for being listed as a qualified medical ... CT protocol reviews and recommends improvements for dosimetry or image quality . + Supports inspections/audits from regulatory/recommending bodies including TJC, PA… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …and guidelines. - Confirms submission documents are accurate, compliant, and high- quality to allow for smooth and expeditious approvals from regulatory authorities. ... with GRA department to execute departmental initiatives to improve overall efficiency, quality , and/or output. - Assess and develop innovative ideas to move GRA… more
- System One (Pittsburgh, PA)
- …proper data collection and analysis. + Ensure data integrity by monitoring data quality and completeness during the trial. Work closely with data management teams to ... all statistical work complies with relevant regulatory guidelines (eg, FDA , EMA) and Good Clinical Practices (GCP). + Use...EMA) and Good Clinical Practices (GCP). + Use statistical software such as SAS, R, or STATA for data… more
- Cook Medical (Pittsburgh, PA)
- …and data mapping documents, and commissioning documents (ie unit tests, software verification tests).* Support the delivery of applications and/or business ... system administrator and/or data administrator.* Develop reporting tools to support quality , including configuration to support data trending and analysis.* Ensure… more
- Envista Holdings Corporation (Quakertown, PA)
- …problem solving. + Collaboration with cross functional teams: mechanical engineering, software engineering, quality engineering, regulatory affairs. + Has ... the leading manufacturer and distributor of innovative dental imaging equipment, software , and solutions. We offer meaningful work through innovation, diverse… more
- Envista Holdings Corporation (Quakertown, PA)
- …the leading manufacturer and distributor of innovative dental imaging equipment, software , and solutions. We offer meaningful work through innovation, diverse ... hub for the design and manufacturing of leading dental imaging devices and software . The facility has a growing, energetic, and diverse mix of professionals spanning… more
- ZOLL Medical Corporation (Pittsburgh, PA)
- …that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide to diagnose and treat patients ... (https://www.zoll.com/products/supersaturated-oxygen-therapy/therox-sso2-system) Super Saturated Oxygen (SSO2) Therapy is the first FDA -approved therapy since the stent 20+ years ago to… more
- Fujifilm (Harrisburg, PA)
- …and processes. + Provides on-going support to resolve application related and image quality concerns on both a product and system level. + Works closely with ... + Ensure compliance with all applicable requirements of the company's quality management system. + Maintains effective communications and working relationships with… more
- ThermoFisher Scientific (Allentown, PA)
- …excels in global clinical supply chain with outstanding dedication to quality and expertise. **Location/Division Specific Information** Our services span project ... + Evaluates and standardizes machine setups to improve both run speed and quality + Provides and maintains other supporting documentation for designs and projects +… more