Johnson & Johnson Careers
Quality System Specialist
Requisition ID: 5379180723
Johnson & Johnson Vision (JJV), a member of Johnson & Johnson's Family of Companies is recruiting for Quality System Specialist, to be located in Milpitas, CA.
JJV, is a worldwide company with operations in the United States, Japan, Latin America, Asia-Pacific and Europe/Middle East/Africa regions. Research, innovation and new-product development are the focus of our organization. Since we introduced soft disposable contact lenses in 1988, and through the acquisition of Abbott Medical Optics in 2017, no other manufacturer has matched the aggressive expansion of our wide-ranging Surgical Vision (Cataracts and Lasik portfolio) and Vision Care (ACUVUE and Consumer Eye Health solutions) family of products. Our associates around the world are committed to expanding the JV brand, and fortifying our position as the worldwide leader in total eye healthcare solutions.
Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science -- bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.
In this role you will provide quality system support establishing and assuring quality system objectives. Assure compliance to applicable regulations. Support Quality System in the areas of Document Management/Control, Training, Management Review preparation, inspection readiness, CAPA/NCR, process improvements and quality metric reporting.
Your responsibilities will be:
- Responsible for compliance with applicable Johnson & Johnson Surgical Vision (JJSV) Policies and procedures.
- Responsible for compliance with applicable Regulatory Requirements, JJSV policies and procedures
- Plans, executes, reports and follows-up on Management Review actions, CAPA actions, NCR or Audit Observations
- Originates Document Change, provides training and supports Quality System projects
- Actively participates on cross-functional team projects in a structured business environment in accordance with internal procedures and external regulations
- Monitors compliance with company policies, procedures and applicable regulatory requirements
- Tracks and reports progress across projects and departmental commitments by reviewing schedules and due dates, identifying risks, and assisting teams with contingency plans
- Assists department and project leaders in developing and reporting appropriate performance and quality metrics
- Able to travel domestic (10% travel, if required to support projects)
- Bachelor's Degree in Engineering/science/technical field
- A minimum of 1 year of experience or a co-op/internship experience in an FDA regulated industry Medical Device
- Experience with Quality Systems based on 21 CFR 820 and ISO 13485 Quality System Requirements.
- ASQ or Industry Recognized Certification desired
- Hands-on knowledge of computer applications including use Word, Excel applications, and presentation software such as Power Point
- Excellent written and oral communication skills
- Excellent organizational skills and presentation skills
- Works well in a team-oriented, cross-functional environment
- Ability to handle multiple tasks and operate in a fast-paced environment
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
AMO Manufacturing USA, LLC (6240)