- United Therapeutics (Boston, MA)
- …their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial ... and are a SME on evaluating and ensuring appropriate quality standards and adherence to case processing procedures. You...vendors and partners to ensure the highest level of quality and compliance with respect to ISCR processing and… more
- Takeda Pharmaceuticals (Lexington, MA)
- …multidisciplinary teams to deliver device clinical outcomes that exceed quality benchmarks and regulatory standards. **Core Responsibilities:** **Device Clinical ... technical requirements + Coordinate risk mitigation activities across clinical, regulatory, quality , and engineering functions + Perform safety reviews on device and… more
- Cambrex High Point (Waltham, MA)
- …Q8/Q9/Q11, FDA /EMA expectations) and process validation. + Familiarity with quality risk management, ICH M4/CTD, and QbD principles. + Excellent problem-solving, ... manufacturing excellence, as well as our strong commitment to quality and safety, we offer a range of career...Together with our customers, we aim to improve the quality of life for patients around the world. Start… more
- Pfizer (Boston, MA)
- …SUMMARY** You will be responsible for scientific oversight, data integrity and quality of clinical trial(s) in support of the development strategy for programs ... the assigned program. + Responsible for scientific oversight, data integrity and quality of the clinical trial(s). + Authors protocols, study level informed consent… more
- Beth Israel Lahey Health (Boston, MA)
- …of personnel. 3. Supervises and directs the work of all operational and quality pathology leaders at BIDMC. Plans, organizes, manages and evaluates all operational ... designed to enhance and support pathology operations to ensure high quality , efficient and cost-effective operations. 4. Ensures appropriate staffing of pathology… more
- Charles River Laboratories (Boston, MA)
- …performing daily animal health observations. Perform animal husbandry duties to maintain quality and health of research animals, to include: perform daily water and ... are met in a timely manner and to agreed quality standards and welfare. + Perform daily cage wash...drugs approved by the US Food and Drug Administration ( FDA ) in the past five years. We're committed to… more
- Fujifilm (Boston, MA)
- …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
- Fujifilm (Boston, MA)
- …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
- Medtronic (Billerica, MA)
- …complex capital equipment systems. + Excellent communication skills. + Knowledge of FDA regulations and medical device quality standards. **Physical Job ... capital systems group in Billerica, you will support the manufacturing of high- quality and complex Capital Equipment Systems to support the Cardiac Ablation… more
- Philips (Cambridge, MA)
- …+ You have a minimum of 5+ years' experience in Post Market Quality /Respiratory Care, with proven experience working within FDA regulated Complaint ... evaluating, investigating, and resolving complaints and upholding high standards of service quality and customer satisfaction. **Your role:** + Manages a team of… more