- ManpowerGroup (Fremont, CA)
- …the Job?** + Lead and support new product development projects to ensure compliance with quality standards and regulations. + Drive design control activities, ... device quality assurance experience. + In-depth knowledge of quality management systems (ISO, FDA , IVDR, QSR). + Proven experience in product and process… more
- BD (Becton, Dickinson and Company) (Columbus, NE)
- …Use trending, metrics, and global issue escalation processes to proactively detect emerging quality risks before they impact product or compliance . + Drive ... **Job Description Summary** The Quality Excellence leader is a globally minded, cross-functional...matrixed environment. + Strong understanding of global regulatory requirements ( FDA , ISO 13485, EU MDR, MDSAP). + Excellent communication… more
- ZOLL Medical Corporation (Pawtucket, RI)
- …files, ensuring compliance with ISO 14971 * Develop and implement quality plans* Ensures post market surveillance reviews are conducted and reports documented ... product and process sustaining activities through the application of Quality engineering skills for medical devices. Focuses on process,...Working knowledge of EN ISO 13485, ISO 14971 and FDA QSR for Medical Devices + Ability to work… more
- Philips (Cambridge, MA)
- …Quality Plan design for hardware and Software design and ensure they meet quality and compliance standards for every planned milestone. Validates key design ... + You have a minimum of 3+ years' experience of Quality Engineering experience within FDA regulated, medical device product environments, with a focus in Design… more
- Danaher Corporation (Chaska, MN)
- …and suppliers to develop and implement robust risk mitigation plans addressing quality , compliance , and supply continuity risks. + Collaborate with ... diagnostic tools that address the world's biggest health challenges. The Global Supplier Quality Engineer - Plastics for Beckman Coulter Diagnostics will serve as a… more
- LISI MEDICAL Remmele (Big Lake, MN)
- … compliance to and providing guidance regarding interpreting ISO 13485 & FDA standards in link with the Manufacturing Quality activities. The Manufacturing ... a part. LISI MEDICAL , is recognized for delivering quality products and innovative services to our customers. Committed...we are committed to our clients to improve the quality of life of patients. Competitive Benefits Include: medical,… more
- Imperative Care (Campbell, CA)
- …bodies (Notified Body, FDA , etc.) and internal audits to maintain regulatory compliance . + Oversee quality and compliance issues, actively resolving them ... ensure compliance with domestic and international regulatory standards (eg, FDA , CE marking, etc.). + Build and sustain relationships with cross-functional peers… more
- GE HealthCare (Chicago, IL)
- …industry. + Minimum of 5 years' Experience driving Global programs to resolve quality compliance issues (directly). + Experience with Pharma QMS requirements and ... **Job Description** **Roles and Responsibilities** + Executes against the Quality & Regulatory Business Development Process. This includes scheduling, preparation,… more
- Catalent Pharma Solutions (Malvern, PA)
- …Malvern site. Catalent is committed to a Patient First culture through excellence in quality and compliance , and to the safety of every patient, consumer, and ... **Operations Quality Specialist** **Position Summary** Catalent, Inc. is a...+ Communications may include educating other functions to ensure compliance to regulations, procedures, and client requirements. + Ensure… more
- Glenmark Pharmaceuticals Inc., USA (Allentown, PA)
- …related experience in the pharmaceutical industry, preferably in QMS and Warehouse Quality compliance . Knowledge and Skills + Excellent communication skills, ... Quality Assurance Associate - Inspection Department: Quality...destruction of pharmaceuticals drug products. + Support regulatory inspections ( FDA , DEA, VAWD/NABP, NJDOH etc.) + Ensure US Allentown… more