- Abbott (Irving, TX)
- …that drive results and continuous improvement. + Knowledgeable of FDA , Quality System Regulations (QSR), Medical Device Directive, ISO guidelines ... spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues… more
- Danaher Corporation (Austin, TX)
- …of the job include: + Bachelor's degree in science with 14+ years of clinical quality /GCP experience within the device industry OR + Master's degree in science ... (ie, TMF, SOP compliance, training, etc.), interface to the FDA and notified bodies, clinical CAPA management, and IVDR...with 12+ years of clinical quality /GCP experience within the device industry +… 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 ... understanding of FDA Quality System Regulation (21 CFR Part 820) + Hands-on experience in incoming inspection and release of goods, with familiarity in … more
- Abbott (Plano, TX)
- …entry of complaints in database. Independently assesses the complaint to determine if a medical device report needs to be filed with various global regulatory ... various types of product complaints; Be able to make sound decisions regarding medical device reporting to various global regulatory agencies, minimizing the… more
- Fotona (Irving, TX)
- …experience in regulatory affairs, legal compliance, or risk management, ideally within the medical device , life sciences, or healthcare sector. + Deep expertise ... for exceptional product performance and versatility, Fotona develops award-winning aesthetic, medical , and dental lasers. With over 50 years of laser expertise… more
- Actalent (Fort Worth, TX)
- …ensure consistent implementation of quality systems. Essential Skills + Medical device quality assurance + FDA regulatory affairs + Process and ... recall activities. + Liaise with regulatory agencies such as FDA , Notified Bodies, and Health Canada. + Develop, implement,... quality and regulatory leadership roles within the medical device industry + Proficiency in additional… more
- Abbott (Plano, TX)
- …spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues ... you dream of. + Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO...to patients throughout the pain continuum. Senior Supplier Development Quality Engineer are responsible for activities related to supplier… more
- ManpowerGroup (Irving, TX)
- …GD&T and inspection standards + Strong computer and communication skills + Medical device or IPC-610-A experience preferred **Interview Process:** In-person ... **Title:** IQA Technician II/ Quality Control Technician **Location:** 1921 Hurd Drive, Irving,...on incoming materials used in the assembly of complex medical devices. Inspections may include visual checks, manual measurements… more
- Steris Corporation (Conroe, TX)
- …ensure the proper documentation and disposition. They may also review other related Quality documentation such as device history or calibration records. The ... and service solutions around the globe. Position Summary The Quality Inspector is responsible for assisting in administration of...to assure adherence to ISO 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, EU MDR and other… more
- Terumo Medical Corporation (Houston, TX)
- …Corporation (TMC) develops, manufactures, and markets a complete, solutions-based portfolio of high- quality medical devices used in a broad range of applications ... drive clear economic value, better clinical outcomes and improved quality of life for patients. TMC is part of...of Tokyo-based Terumo Corporation; one of the world's leading medical device manufacturers with $6+ billion in… more