Job Description

Johnson & Johnson Surgical Vision, Inc., a member of the Johnson & Johnson Family of Companies, is recruiting for a Staff Product Escalation Quality Specialist! Consideration for remote employees located in the United States may be given, except the position may not be located in Colorado.

At Johnson & Johnson Vision, we have a bold ambition: to change the trajectory of eye health. Thats why, through our operating companies, weve developed solutions for every stage of lifeto help people see better, connect better and live better. We partner with eye care professionals to provide some of the worlds leading products and technologies to address refractive error, cataracts, dry eye, and beyond. We are committed to using our reach and size for good, and strive to put quality eye care within reach of everyone, everywhere. Visit us at www.jjvision.com. Follow @JNJVision on Twitter and Johnson & Johnson Vision on LinkedIn.

Our company thrives on a diverse company culture, celebrating the uniqueness of our employees and is committed to inclusion. J&J; Vision is proud to be an equal opportunity employer. Our culture is interconnected by the shared values of Our Credo. It is a culture that celebrates diversity and diverse perspectives, and helps its employees achieve an effective balance between work and home life and supports their efforts to have a positive impact on their communities.

Are you interested in joining a company where you will work with team members worldwide while gaining valuable experience in leadership, collaboration, and developing innovative solutions to complex problems? Apply today for this exciting opportunity!

The Staff PE Quality Specialist will be responsible for providing overall quality assurance leadership in the management of J&J; Vision's Product Escalation (PE) and Field Action (FA) process. They will be a knowledge source for our PE & FA process within the J&J; Vision Quality organization. They will prepare, monitor, and report on post market compliance trends as well as audit results. They will also be responsible for partnering with key stakeholders to ensure robust and compliant processes. They maintain quality assurance procedures and control, ensuring that the PE & FA process is executed according to company requirements.

Key Responsibilities:

* Responsible for compliance to Field Actions (FAs), Product Escalations (PEs), Nonconformance (NC), and Corrective and Preventative Action (CAPA) processes as well as Medical Device regulations and requirements.
* Provide expertise and guidance in interpreting governmental regulations, agency guidelines, and internal policies to assure compliance relative to PEs/FAs/NC/CAPA.
* Act as liaison between the company and the various governmental agencies during audits.
* Work directly with J&J; operating entities to ensure that investigations are conducted to meet procedure requirements.
* Ensure accuracy and completeness of pertinent records and documentation.
* Perform quality processes including data analysis, change control, NC, CAPA, FAs and PEs.
* Maintain, support compliance of, and improve PE & FA processes.
* Coordination of field action activities including preparing documentation for recordable and reportable field actions.
* Lead or participate in process improvement projects as required to support strategic business objectives.
* Interact with internal and external partners.

Qualifications
Education:

* Minimum Bachelor's Degree (BS/BA) in technical or life science, or related area is required

Skills and Experience:

Required:

* Minimum 6 years of relevant work experience
* Experience in the Quality field within a regulated industry
* Excellent written and verbal communication skills, with the ability to write for external regulators, internal leaders, and others as required
* Work experience with NC/Event Management and Change Control; continuous improvement projects are a plus
* Ability to review and analyze documentation critically and logically
* Experience working in a cross-functional environment
* Ability to work independently on work assignments with minimal oversight

Preferred:

* Experience in healthcare regulated industry (e.g., Medical Device or Pharmaceutical/Biotech)
* Experience working on Recalls/Field Actions
* Demonstrated strong expertise with multiple root cause analysis and problem-solving methodologies
* FDA and/or ISO regulations knowledge (e.g., 21 CFR 820; 21 CFR 210/211; ISO 13485; ISO 14971)

Other:

* Requires up to 10% domestic travel

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-Santa Ana-1700 E Saint Andrew Place
Other Locations
United States, United States-California-Santa Ana, United States-Florida-Jacksonville
Organization
Johnson & Johnson Surgical Vision, Inc (6234)
Job Function
Quality
Requisition ID
2105896489W