Change Control Manager

Biosense Webster/Acclarent is hiring for a Change Control Manager located in Irvine, CA.

At Biosense Webster, Inc. we have one goal — to ensure those with cardiac arrhythmias can live the lives they want. This means transforming the latest advancements in electrophysiology into a suite of tools that empowers physicians with a range of treatments for the best outcomes.

Quality products and approaches are achievable only through collaboration with the smartest minds in electrophysiology. For more than 30 years, we’ve been the global market leader in the science and technology of cardiac arrhythmia treatment, working with thousands of electrophysiologists to identify and develop diagnostic and treatment tools. And through onsite training, online courses and our global education centers, we work together to set new standards every day.

Learn more about Biosense Webster at www.biosensewebster.com and follow us on LinkedIn.

Chronic sinusitis affects 3 million Americans each year and five per cent of the U.S. adult population suffers from a phenomenon referred to as Eustachian Tube Dysfunction (blocked ears / ear pain). Acclarent, Inc. is dedicated to supporting otolaryngologists with minimally-invasive ENT technologies that relieve this suffering as effectively and painlessly as possible. For more than a decade Acclarent, Inc. has pioneered innovative technologies, including the balloon dilation system that’s been used to treat more than one million patients.

 

Job Description:

The Cardiovascular and Specialty Solutions (CSS) Document and Change Management Supervisor is responsible for managing the Document and Change Management Process across CSS and provides direct oversight for the Biosense Webster (BWI) and Acclarent change control groups, including leading document control daily activities, supporting new product development (NPD) projects, ownership of the periodic review process, monitoring Change Control metrics, and supporting Product Lifecycle Management (PLM) systems upgrades and deployments to the business.

 

Under limited supervision and in accordance with all applicable federal, state, and local laws/regulations and Corporate Johnson & Johnson (J&J), procedures and guidelines, this position:

 

• Manages periodic review process and procedures for CSS sites in applicable PLM Systems. Partners with Medical Device (MD) Document and Change Management leaders to identify continued process improvements and enhancements
• Drives continuous improvement of document management processes within MD, actively seeks methods to reduce cycle times
• Executes Franchise-specific and J&J MD strategies to standardize and optimize processes where appropriate
• Leads and trains groups to required procedures and processes
• Coaches and develops team based on yearly development plans and goals and objectives
• Prioritizes approval and release of Change Control documents based on business priorities
• Leads or supports special assignments or projects, as needed, such as acquisitions/divestures, deployment of new applications or processes, continuous improvement efforts, or business projects such as new product development
• Addresses issues related to document and change management for internal and external (FDA, BSI, etc.) audits as needed
• Investigates and resolves non-conformances, audit observations, corrective and preventive actions (CAPAs) related to Documentation Services
• Assists in the creation and development of metrics to evaluate the effectiveness and efficiency of Document Change Control Processes
• Communicates business related issues or opportunities to next management level

• Ensures 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
• Ensures personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
• Performs other duties assigned as needed

Qualifications

Required

• Bachelor’s degree in Science/Engineering plus 5 years of experience or a bachelor’s degree in non-Science/Engineering plus 7 years of experience
• 8 years of experience in a Medical Device environment
• 4 years of experience in document management or using an electronic document management system
• 2 years of management experience
• Proficient in Microsoft Office Applications, Adobe Acrobat, and database application
• Ability to multitask, including ability to understand customer requirements, retrieve information, and provide responses satisfactorily and with immediacy
• Ability to learn and manipulate complex computer system applications
• Knowledge of GDP, 21 CFR Part 820 (QSR) and ISO 13485 (QMS) requirements
• Experience providing support for internal audits and inspections by regulatory authorities.
• Experience with CAPA, non-conformances, and internal audit processes
• Experience in working with product development and/or manufacturing
• Excellent interpersonal & communications skills
• Excellent time management and problem-solving skills
• Detail oriented and accurate
• Ability to work in a fast-paced environment and rapidly shift priorities
• Ability to quickly adapt and navigate various technology and computer software
• Ability to communicate with multiple levels of management

 

Preferred

• Master’s degree in Science/Engineering
• CQE certification from the American Society for Quality (ASQ)
• Experience in developing and motivating direct employees is preferred
• Six Sigma training and/or certification

 

Other

• The anticipated base pay range for the position is $97,000 to $145,000.
• The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/ performance year. Bonuses are awarded at the Company’s discretion on an individual basis.
• Employees may be eligible to participate in Company employee benefit programs such as health insurance, savings plan, pension plan, disability plan, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans. Additional information can be found through the link below.
• For additional general information on company benefits, please go to: https://www.careers.jnj.com/employee-benefits

 

At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional, and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work.

 

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.

 

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
2206080825W

Salary : $97,000 - $145,000