Senior Quality Engineer Risk Management - Irvine
Company: johnson&johnson
Location: Irvine
Posted on: August 5, 2022
|
|
Job Description:
b'This position will have responsibilities in the implementation
and coordination of Risk documents across BWI. Biosense Webster,
Inc., part of Johnson & Johnson Medical Devices Companies, is a
global leader in the science of diagnosing and treating heart
rhythm disorders. The company partners with clinicians to develop
innovative technologies that improve the quality of care for
arrhythmia patients worldwide. For more information, visit This
position may have responsibilities across ETHICON and
Cardiovascular and Specialty Solution (CSS) Companies Johnson and
Johnson Family of Companies) including a span of multiple product
platforms such as General Surgical Devices, Sutures, ENT, Infection
Prevention, Electrophysiology and Surgical and Non-Surgical
Aesthetics. RESPONSIBILITIES Under limited supervision and in
accordance with all applicable federal, state and local
laws/regulations and Corporate Johnson & Johnson, procedures and
guidelines: /xe2/x80/xa2 This position will support day-to-day
responsibilities of maintaining the Risk Management System in
accordance with ISO14971 and all Corporate, MD and CSS Standards.
/xe2/x80/xa2 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.
/xe2/x80/xa2 Reviews and continuously leads efforts to improve the
Risk Management System at BWI /xe2/x80/xa2 Maintains dashboards and
other reports of performance metrics as required. /xe2/x80/xa2
Provides regular updates and status reports to management.
Initiates Company issue escalation process as required.
/xe2/x80/xa2 Remains informed of new or revised regulations and/or
guidelines and assesses impact on company Risk Management
processes. /xe2/x80/xa2 Supports internal and external audits (e.g.
FDA) of risk management activities. Essential functions are the key
tasks and responsibilities of the specific job, for example:
/xe2/x80/xa2 Support ongoing maintenance of the Risk Management
files for all current marketed product in accordance with all
applicable requirements. /xe2/x80/xa2 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. /xe2/x80/xa2 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. /xe2/x80/xa2 Responsible for communicating business
related issues or opportunities to next management level
/xe2/x80/xa2 Responsible for ensuring personal and Company
compliance with all Federal, State, local and Company regulations,
policies, and procedures /xe2/x80/xa2 Performs other duties
assigned as needed Qualifications /xe2/x80/xa2 A
Bachelor/xe2/x80/x99s degree in Science, Engineering, Biology,
Chemistry or related technical field is required. /xe2/x80/xa2 4+
years of related experience, including significant experience
working in pharmaceutical, consumer, medical device or another
highly regulated industry. /xe2/x80/xa2 At least 2
years/xe2/x80/x99 experience in the Electrophysiology field is
required. /xe2/x80/xa2 The following skills, abilities and
certifications are either required or preferred as noted: Critical
thinking and investigation skills are required. Ability to
multitask, including ability to understand customer requirements,
retrieve relevant information, and provide responses satisfactorily
and with immediacy is required. /xe2/x80/xa2 Candidates should be
familiar with general quality management system concepts, including
good documentation practice (GDP), corrective and preventive action
(CAPA), and document change control practices. /xe2/x80/xa2 Ability
to function in a team environment and deliver on team objectives is
required. /xe2/x80/xa2 Professional demeanor on the phone and in
email is required. /xe2/x80/xa2 Strong attention to detail is
required. /xe2/x80/xa2 Require prior medical device complaint
handling experience, or knowledge of medical device regulations is
required. /xe2/x80/xa2 Project management and/or process mapping
experience. /xe2/x80/xa2 Strong written and verbal communication
skills are required. /xe2/x80/xa2 Developed presentation skills
Johnson & Johnson is an Affirmative Action and Equal Opportunity
Employer. All qualified applicants will receive consideration for
employment without regard to race, color, religion, sex, sexual
orientation, gender identity, age, national origin, or protected
veteran status and will not be discriminated against on the basis
of disability. Primary Location United States-California-Irvine-31
Technology Dr Organization Biosense Webster Inc. (6010) Job
Function Quality Requisition ID 2105978461W'
Keywords: johnson&johnson, Irvine , Senior Quality Engineer Risk Management - Irvine, Executive , Irvine, California
Click
here to apply!
|