- Christus Health (Sulphur Springs, TX)
- …Quality Control/ Quality Assurance in accordance with MQSA programs and ACR, FDA , and State standards and regulations. Assures that all documentation is accurately ... needed. Troubleshoots and reports any equipment malfunctions to the Director/ Manager /Supervisor and/or Biomedical personnel; does appropriate follow-up. Performs other… more
- Zimmer Biomet (Austin, TX)
- …empowered and recognised. **What You Can Expect** As a **Software Quality Manager ** you will be responsible for ensuring the quality, safety, and compliance ... validation, verification, regression testing, and cybersecurity to ensure compliance with FDA , ISO 13485, IEC 62304, and ISO 14971 standards. Monogram's… more
- Grifols Shared Services North America, Inc (Nacogdoches, TX)
- …of operational priorities, and provides direct support to the Center Manager in driving performance, donor satisfaction, and continuous improvement. **Primary ... Responsibilities** + Serves as acting leader in the absence of the Center Manager as assigned. Maintains the ability to perform any/all tasks within the plasma… more
- Oracle (Austin, TX)
- …EHR and AI-enabled medical device platforms. As a Clinical Product Manager (Medical Device Focus), you'll provide clinical insight into product design, ... Clinical Evaluation Reports (CERs), including alignment with EU MDR and FDA regulatory requirements. . Oversee usability engineering (IEC 62366), ensuring… more
- Oracle (Austin, TX)
- …EHR and AI-enabled medical device platforms. As a Clinical Product Manager (Medical Device Focus), you'll provide clinical insight into product design, ... Clinical Evaluation Reports (CERs), including alignment with EU MDR and FDA regulatory requirements. . Oversee usability engineering (IEC 62366), ensuring… more
- J&J Family of Companies (Irving, TX)
- …**Job Description:** Johnson & Johnson is currently recruiting a Senior Quality Manager to join our Aesthetics & Reconstruction (A&R) organization in Irving, Texas. ... & Deployment responsibilities for the A&R Quality organization. The Senior Quality Manager will ensure the highest standards of quality across our supplier network… more
- Edwards Lifesciences (Austin, TX)
- …+ As a key member of the Medical Affairs Clinical Science team, the Senior Manager (formal internal title is Senior Manager , Medical Affairs) is responsible for ... a dynamic portfolio of products across TMTT. The Senior Manager will be an experienced medical device professional with...and EU MDR for clinical evaluations. + Experience with FDA PMA applications. + Strong knowledge of scientific research… more
- Otsuka America Pharmaceutical Inc. (Austin, TX)
- …products and drug-device combination products. Ensure compliance with global regulations ( FDA , EMA, ICH, WHO) and anticipate regulatory changes impacting CMC ... for investigational, marketed product submissions (IND/IMPD/NDA/MAA/DMF, post-approval supplements) for FDA and equivalent submissions for Europe and Canada. +… more
- Schwan's Company (Pasadena, TX)
- …just a job, it's a seat at the table! We are hiring a Sanitation Manager for our Houston, TX (specifically: Pasadena and Deer Park) food manufacturing facilities. In ... Sanitation Operating Procedures), HACCP (Hazardous Analysis Critical Control Points), FDA (Food & Drug Administration), and GMP (Good Manufacturing Practices).… more
- Otsuka America Pharmaceutical Inc. (Austin, TX)
- The **Global Quality Audit Manager ** is responsible for planning, executing, and reporting on global audits to ensure **Good Clinical Practice (GCP) compliance** ... a key member of the Global Quality Management team, the Audit Manager will collaborate with cross-functional stakeholders to identify risks, drive continuous… more
