Johnson & Johnson Careers
Manager, Risk Management
Requisition ID: 2462180920
Johnson & Johnson’s Cardiovascular & Specialty Solutions (CSS) Group within Medical Devices is recruiting for a Manager, Risk Management for Biosense Webster located in Irwindale, CA or Irvine, CA. The CSS Group serves a diverse base of customers in Ear, Nose and Throat (ENT), Infection Prevention, Cardiovascular/Electrophysiology (EP), Surgical and Non-Surgical Aesthetics, Neurovascular and Reprocessing.
Biosense Webster is the global leader in the science of diagnosing and treating heart rhythm disorders and one of the fastest-growing businesses within Johnson & Johnson.
The Manager, Risk Management will participate in new product/process and QMS teams to manage risks across Biosense Webster and Coherex Medical (BWI). This position will be responsible for the management and leadership of the Quality Risk Management Organization.
DUTIES & RESPONSIBILITIES
Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, the Manager, Risk Management will:
- Have overall responsibility for day-to-day responsibilities of maintaining the Risk Management System in accordance with ISO14971:2012 and all Corporate, MD and CSS Standards.
- Lead a team of individuals, the position will be responsible for the ongoing maintenance of the Risk Management files for all current marketed product and supporting the Risk assessment in the QMS (i.e. NC, CAPA, IE, Change control etc.) in accordance with all applicable requirements.
- Utilize Quality Engineering tools/processes in development and implementation of Risk assessments of products/processes throughout the product lifecycle.
- Interact with the Complaints Management Department (CMD) and Post Marketing Surveillance Group (PMS) in order to provide updates to the applicable risk documents. Additionally, the position will work to improve the systems utilized within the New Product Development groups ensuring compliance to existing procedures and uniformity of risk assessments performed on new products.
- Lead continuous improvement activities and providing subject matter expertise on Risk Management requirements.
- Review and continuously lead efforts to improve the Risk Management System at BWI including New Product Development.
- Maintain and continuously improve highly effective procedures for Risk Management. Drives harmonization across the network.
- Collaborate with the, Medical Safety, Medical Affairs, Manufacturing, New Product Development (NPD)/Life Cycle Management (LCM) Teams and other departments to ensure compliance with applicable risk standards. May participate in the generation of risk documents as part of the applicable design phase within the Product Development Process.
- Maintain dashboards and other reports of performance metrics as required.
- Provide regular updates and status reports to Senior Management. Initiates Company issue escalation process as required.
- Participate in the Health Hazard Evaluation Process as the Quality Representative.
- Approve regulatory reports for submission to US FDA and other regulators.
- Draft response communications to inquiries from regulators.
- Remain informed of new or revised regulations and/or guidelines and assesses impact on company Risk Management processes.
- Support internal and external audits (e.g. FDA) of risk management activities.
- Collaborates closely with other CSS departments to maintain compliance within the Customer Quality process.
- Be responsible for communicating business related issues or opportunities to next management level
- Ensure that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
- Ensure personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
- Perform other duties assigned as needed
- A Bachelor’s degree is required, with a preference for focus in Science, Engineering, Biology, Chemistry or related technical field.
- At least 8 years of relevant experience in pharmaceutical, consumer, medical device OR another highly regulated industry is required.
- Experience in the Electrophysiology field is an asset.
- Familiarity with general quality management system concepts, including good documentation practice (GDP), corrective and preventive action (CAPA), and document change control practices is required.
- Experience managing/coaching/developing people and managing projects is an asset.
- Experience on Risk Management Activities and exposure with the Medical Safety Committee is preferred
- Green Belt / Lean Manufacturing Certification, Six Sigma is preferred
- ASQ Certification (i.e CQA/CQE) is preferred
- Previous experience working with the FDA and notify bodies is an asset.
- Proficiency with MS Office (word, excel, power point, outlook, etc.) is required.
- Excellent verbal and written communication skills, and strong interpersonal, leadership, and analytical skills are required
- This position may be located at our company site in Irwindale, CA or Irvine, CA, and may require up to 20% travel, both domestic and international.
Biosense Webster Inc. (6010)