- Abbott (Plano, TX)
- …of product complaints; Be able to make sound decisions regarding medical device reporting to various global regulatory agencies, minimizing the need for ... extracted from the complaint database to various teams (eg Regulatory , Quality Engineering). Another role of the...database. Independently assesses the complaint to determine if a medical device report needs to be filed… more
- Abbott (Irving, TX)
- …business competencies that drive results and continuous improvement. + Knowledgeable of FDA, Quality System Regulations (QSR), Medical Device Directive, ISO ... spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues… more
- ARTIDIS (Houston, TX)
- …experience in Quality Assurance or Quality Control, ideally within a medical device or diagnostics environment + Sound knowledge of ISO 13485:2016 and an ... patients' needs and desired outcomes. Job Purpose The Material Handling & Quality Assurance Specialist ensures the seamless and compliant flow of materials and… more
- Astrix Technology (San Antonio, TX)
- …field). + 2+ years of leadership experience + GMP manufacturing experience within Medical Device , Pharmaceutical, Biotech or related industry + ISO 13485, ISO ... ** Quality Manager** Quality Control San Antonio,...lab operations. + Ensure compliance with internal policies and regulatory standards (eg, cGMP). + Plan and coordinate testing… more
- Houston Methodist (Houston, TX)
- …+ Proven ability to manage large-scale datasets including data cleaning, validation, and quality control + Proficiency in REDCap and ArcGIS for data capture and ... ESSENTIAL FUNCTIONS** + Coordinates with CMP staff for the emerging GLP device studies. + Assists in the preparation and coordination of business development… more
- Bausch + Lomb (Austin, TX)
- …Management, Clinical/ Medical Affairs, Biometrics, Regulatory Affairs, Quality Assurance, Pharmacovigilance/GPSS and Drug/ Device Safety, and Clinical ... provide input on study-related documents and issues (DMP, SAP, drug/ device supplies, CSR, etc.). + Provides clinical operations input...ICH, GCP and B&L SOPs. + Responsible for the quality of all study-related documentation (eg, Trial Master File,… more
- ARTIDIS (Houston, TX)
- …The Application Customer Service assumes a pivotal role within the realm of medical device operations, leveraging their expertise and experience to propel ... or service attains the highest caliber in terms of quality standards and regulatory compliance. This job...tissue/cell nanomechanics, sample preparation, data analysis, and validation. + Medical Device Knowledge: Proficient in medical… more
- ZOLL Medical Corporation (Dallas, TX)
- …and present information clearly + Proven knowledge and understanding of the medical device field + Ability to work effectively with cross-functional ... that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide...normal breathing pattern during sleep and give them better quality of life. We develop breakthrough therapies for an… more
- MD Anderson Cancer Center (Houston, TX)
- …Engineering SME on various institutional initiatives including but not limited to, Medical Device Governance with emphasis on Cybersecurity measures, SCORE ... medical technology / equipment SME, in terms of regulatory requirements, compliance measures and technology sustenance / maintenance...(Huron Group) program, FDA GRC / Info-Sec Medical Device Classification and continuous efforts to… more
- Fotona (Irving, TX)
- …in regulatory affairs, legal compliance, or risk management, ideally within the medical device , life sciences, or healthcare sector. + Deep expertise in FDA ... for exceptional product performance and versatility, Fotona develops award-winning aesthetic, medical , and dental lasers. With over 50 years of laser expertise… more