Posted: Monday, March 13, 2017 5:17 PM
Why join Boston Scientific Neuromodulation in California?
We integrate all global operations at our worldwide headquarters in Valencia, California, close to Los Angeles, close to the beach, close to the mountains, close to the desert. All the advantages of Southern California but more affordable than many other areas nearby. If you are looking for onsite amenities we have an on:campus bistro, credit union, brand new gym, and Toastmasters club. Take advantage of 300+ days of sunshine a year on our basketball and volleyball courts. Join our softball and soccer teams. We even have cricket and dragon boat racing teams We are a community leader and as such we offer numerous volunteer activities and events in the wonderful cities of Valencia and Santa Clarita. If you like to work hard and play hard, youll fit right in. And youll be well rewarded. Our salaries are competitive. Our benefits package is generous. And Forbes ranks our 401K program as one of the top 10 in the country
What makes Boston Scientific Neuromodulation so special?
Weve seen the difference that Neuromodulation technology such as spinal cord stimulation and deep brain stimulation can make. These breakthroughs have helped more than 400,000 people worldwide over the past four decades. But there is still enormous potential to help even more people. In our drive to be the world leader in neurological devices, we strive to improve every life we touch through our dedication to innovation, our commitment to people, and our passion for performance.
Assists the Manager, Clinical QA, with internal quality assurance program for the assigned business area. Serves as clinical QA representative on clinical project teams and conducts internal and external quality audits to assure that BSC clinical trials comply with all applicable regulatory requirements and BSC policies and procedures. Supports Inspection Readiness, Clinical Corrective and Preventative Action (CAPA) and acquisition integration.
: Participates on clinical project teams, influences clinical teams toward a state of inspection readiness at all times
: Plans, schedules, and conducts internal and external quality assurance audits of the systems, clinical investigative site audits, procedures, and controls employed in the design, conduct, and analysis of clinical trials.
: Assesses sponsor/investigator/monitor compliance with protocol, GCP and applicable regulatory requirements and relevant BSC policies and procedures
: Assesses the accuracy, validity, and quality of the scientific data generated during clinical trials
: Participates in problem:solving with project teams at investigator sites
: Communicates observations to clinical investigators and clinical program managers,
: Documents audit observations; evaluates impact and responses to audit findings and ensures the appropriate corrective actions are completed
: Ensures tracking of audit findings
: Contributes to the development of audit procedures and processes
: Assists clinical QA Managers with annual audit planning, review and trending of audit results, and development and implementation of improvement initiatives.
: Supports the preparation, coordination, and management of regulatory agency sponsor inspections of BSC offices
: Assists in preparation of investigator sites for FDA or other regulatory agency inspections and assists in preparation of written responses to findings
: Keeps abreast of and interprets current worldwide regulatory requirements; advises management on the possible ramifications of regulatory changes.
: Support to the Clinical organization in meeting BSC Quality system requirements
: Supports the CAPA process, working cooperatively with Clinical NCEP/CAPA owners providing quality input
: May support clinical integration teams o
• Location: San Fernando Valley
• Post ID: 103972913 sanfernandovalley