Quality System Specialist

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Job Description

Johnson & Johnson Vision, part of Johnson & Johnson Family of Companies is recruiting for a Quality System Specialist.

At Johnson & Johnson Vision, we have a bold ambition: to change the trajectory of eye health. That’s why, through our operating companies, we’ve developed solutions for every stage of life—to help people see better, connect better and live better. We partner with eye care professionals to provide some of the world’s 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 Follow @JNJVision on Twitter and Johnson & Johnson Vision on LinkedIn.

The Quality System Specialist is responsible for translating regulatory standards and business processes into documented quality systems. Also handles document updates and revisions. Supports Quality System Department in the areas of Metrics Monitoring, Management Review, Inspection Readiness and Other Quality System Projects. 

You will:
Provide QA technical and compliance expertise in establishing and assuring quality system objectives. Assure compliance to applicable regulations. Perform activities such as Management Review preparation, Inspection readiness, procedure development/update, process improvements and quality metric reporting.

Ensures quality systems are effectively deployed. Performs periodic checks to verify appropriate application. Uses basic statistical methods, quality tools and computer-generated reports to continuously improve Quality System. Participates in quality system improvement initiatives. Initiates Document Changes based on input provided. Processes the Document Changes through Change Management System. Assists in internal audits to determine compliance with quality management system standards as well as regulatory and customer requirements. Assists in determining root causes of quality issues and develops corrective action and recommendations. Suggests process change recommendations, as appropriate. Establishes, maintains and implements communications to increase awareness and promote improvement of quality issues across the business. Assists with external audits, generating reports with corrective action plans and ensuring implementation of corrective actions in a timely fashion. 

Main areas of responsibility in addition to items listed above
• Responsible for compliance with applicable Johnson & Johnson Surgical Vision (JJSV) Policies and procedures.
• Responsible for compliance with applicable Regulatory Requirements, JJSV policies and procedures
• Able to travel domestic and international (10% travel, if required to support projects)
• Plans, executes, reports and follows-up on Management Review actions, CAPA actions, NCR or Audit Observations
• 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

• University/Bachelor’s Degree or Equivalent is required.
• Requires 2 Years of Work Experience
• Experience with Quality Systems based on 21 CFR 820 and ISO 13485 Quality System Requirement is required.
• ASQ or Industry Recognized Certification is preferred.
• Hands-on knowledge of computer applications including use Word, Excel applications, and presentation software such as Power Point is required.
• Experience in External Quality System Audits and Internal Quality System Audits is preferred
• Experience in Quality Management Review is preferred
• Experience in CAPA (Corrective Action and Preventive Action) is preferred

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-Milpitas-
AMO Manufacturing USA, LLC (6240)
Job Function
Quality Systems
Requisition ID