Job Title
Quality Engineer 2 – Risk Management
Company
Johnson & Johnson
Job Description
Biosense Webster is recruiting for a Quality Engineer 2 – Risk Management , located in Irvine, CA.
Biosense Webster 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 www.biosensewebster.com.
The Quality Engineer 2 – Risk Management, executes, and coordinates quality assurance activities intended to ensure effective product quality processes are in place and executed throughout lifecycle of product. Involved in New Product Development (NPD) teams, partnering with Post market Surveillance team, and other activities for implementation and coordination of Risk documents across Biosense Webster Inc.
Duties include:
Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, 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.
- Is 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
- 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.
- 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.
- Support 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 used 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.
- Responsible for communicating business related issues or opportunities to next management level
- Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures Working with other functional groups, including R&D and Operations in support of new product development, engineering projects, quality assurance activities, and lifecycle management.
- Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
Qualifications
Required :
- Bachelor’s degree, required; preferably in engineering and/or scientific field
- A minimum of 2 years of quality, manufacturing, or research and development experience in a medical device or other regulated industry
- Ability to define problems, collect and analyze data, establish facts, and draw conclusions and recommendations
Critical thinking and investigation skills * Ability to multitask, including ability to understand customer requirements, retrieve relevant information, and provide responses satisfactorily and with immediacy
- Ability to function in a team environment and deliver on team objectives
Preferred:
- Familiar with general quality management system concepts, including good documentation practice (GDP), corrective and preventive action (CAPA), and document change control practices
- Strong attention to detail
- Prior medical device complaint handling experience, or knowledge of medical device regulations
- Project management and/or process mapping experience.
- Strong written and verbal communication skills
- Developed presentation skills
- Six Sigma/ Design for Six Sigma experience, and/or knowledge of Process Excellence tools
- Lean manufacturing experience
- Knowledge of Quality and operations systems and processes, including GMP
Other :
- This position is located in Irvine, California and will require up to 20% travel domestic and international.
The anticipated base pay range for this position is $61,000 to $97,000.
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.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com (http://www.careers.jnj.com).
Expected Salary
$61000 – 97000 per year
Location
Irvine, CA
Job Posting Date
Thu, 12 Oct 2023 07:57:30 GMT