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Staff Quality Engineer

TheCardiovascular & Specialty Solutions (CSS) Group, part of the MedicalDevices sector within Johnson & Johnson, is recruiting for a StaffQuality Engineer in Irwindale, CA.
TheCSS Group consists of six diverse businesses including Acclarent, AdvancedSterilization Products (ASP), Biosense Webster (BWI), Codman Neuro, Mentor, andSterilmed. The CSS Group serves a diverse base of customers in Ear, Nose andThroat (ENT), Infection Prevention, Electrophysiology (EP), Neurovascular andNeurosurgery, Surgical and Non-Surgical Aesthetics, and Reprocessing.
Thisposition is primarily specific to Biosense Webster.
JOB SUMMARY
This positionwill have responsibilities in planning, implementing, execution, standardizing,coordinating, and managing Risk documents across BWI.
DUTIES & RESPONSIBILITIES
Under (e.g. limited supervision, general direction, etc.)and in accordance with all applicable federal, state and local laws/regulationsand Corporate Johnson & Johnson, procedures and guidelines, this position:
This position will have overlap responsibility with the manager for the 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.
Leading a team of individuals, the position will be responsible for the ongoing maintenance of the Risk Management files for all current marketed product in accordance with all applicable requirements.
Reviews and continuously leads efforts to improve the Risk Management System at BWI including New Product Development.
Maintains dashboards and other reports of performance metrics as required.
Provides regular updates and status reports to management. Initiates Company issue escalation process as required.
May participate in the Health Hazard Evaluation Process as the Quality Representative.
Approves regulatory reports for submission to US FDA and other regulators.
Drafts response communications to inquiries from regulators.
Remains informed of new or revised regulations and/or guidelines, and assesses impact on company Risk Management processes.
Supports internal and external audits (e.g. FDA) of risk management activities.
Leading a team of individuals for the ongoing maintenance of the Risk Management files for all current marketed product in accordance with all applicable requirements.
The role requires interaction with the Complaints Management Department (CMD) and Post Marketing Surveillance Group (PMS) 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.
Collaborates 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.
Essential functionsare the key tasks and responsibilities of the specific job, for example:
QUALIFICATIONS:
The following skills,abilities and certifications are either required or preferred as noted.
o A Bachelor's degreein Science, Engineering, Biology, Chemistry or related technical field isrequired.
o 4 years of relatedexperience, including significant experience working in pharmaceutical,consumer, medical device or another highly regulated industry.
o At least 2 years'experience in the Electrophysiology field is required.
o Critical thinking andinvestigation skills are required.
o Ability to multitask,including ability to understand customer requirements, retrieve relevantinformation, and provide responses satisfactorily and with immediacy isrequired.
Candidates should befamiliar with general quality management system concepts, including gooddocumentation practice (GDP), corrective and preventive action (CAPA), anddocument change control practices.
Ability to functionin a team environment and deliver on team objectives is required.
Professional demeanoron the phone and in email is required.
Strong attention todetail is required.
Require prior medicaldevice complaint handling experience, or knowledge of medical deviceregulations is required.
This position is located in Irwindale, CA and may require some travel.

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