Analyst 1, Quality Assurance

Job description

Johnson & Johnson Vision is currently recruiting for a Analyst 1, Quality Assurance to be located in Santa Ana, CA.

Johnson & Johnson Vision is committed to improving and restoring sight for patients worldwide. Since debuting the world's first disposable soft contact lens in 1987, it has been helping patients see better through their world-leading ACUVUE® Brand Contact Lenses. In 2017, J&J expanded into cataract surgery, laser refractive surgery (LASIK) and consumer eye health and now serves more than 60 million patients a day across 103 countries with its eye health portfolio. Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.

The Analyst 1, Quality Assurance will evaluate and take appropriate actions based on internal and external standards for all Johnson & Johnson surgical Vision (JJSV) product and procedure releases and modifications. Analyse and interpret data, using independent judgement to approve, reject, release or rework change documentation submissions on a case by case basis. Analyze and review submissions based on product type, development lifecycle stage and the interpretation of the significance of the proposed change.

In this role you will:

· Independently assess and judge proposed product and procedure changes for compliance to regulatory and business standards.
· Conduct final configuration verification prior to product release or change implementation in Document Management System and ERP system.
· Monitor, direct actions and/or escalate issues regarding the change processing status to meet project plan release deadlines.
· Guide change initiators in the development of accurate changes
· Create and implement system processing improvements

Desired profile

Qualifications :

Requirements:

·  High School Degree is required, a Bachelor's degree is preferred
·  Minimum of 2 years experience in a highly regulated industry, preferably in medical devices
·  Experience with MD office and ERP- Enterprise Resource Planning systems are required
·  Experience in product lifecycle management systems (e.g. Agile) is preferred
·  The ability to read, communicate (both verbally and written) in Spanish and/or Chinese is preferred
·  The ability to interpret and analyze diverse submission and assess compliance to standards utilizing independent judgement consistently and appropriately is required
·  Customer driven with sense of urgency/priority in responding to customers' needs is needed in this role
·  Demonstrated ability to communicate effectively, with clear and concise oral and written communication is required