Johnson & Johnson’s Surgical Vision Group within Medical Devices is recruiting for a Customer Quality Analyst II for our Product Safety Team in Santa Ana, CA, or remote for the right candidate JJSV designs manufacture and distribute products for the surgical treatment of anterior segment ophthalmic disorders, most notably cataract removal.
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 www.jjvision.com.
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This position supports the product complaint program including initial complaint assessment and identification of complaints related to adverse events.
Analyzes incoming product complaints, determines requirements for investigation, investigates and evaluates complaints, and finds solutions to customer issues.
This individual is responsible for maintaining the quality processes related to JJSV post-market product complaints and ensure compliance with all applicable Corporate and Divisional Policies and procedures.
Demonstrates thorough understanding of quality management standards as outlined in Good Manufacturing Practices (GMPs), FDA Code of Federal Regulations (CFRs), and ISO 13485.
Actively participates in the departmental process improve.
Responsibilities Manages individual complaints on various JJSV product lines, from opening to closing.
Performs accurate and timely data entry in corporate complaint database Coordinates complain investigations, including determining investigation strategies, as needed with internal and external resources Makes decisions related to reportability of product complaints and prepares/submits reports to regulatory authorities in timely manner Communicates directly with JJSV customers regarding reported complaints and resolutions Analyzes complaint data to identify any trends and provides information to department management and other personnel that may lead to a Corrective Action Request Works with other departments and vendors on known or emerging issues to resolve quality problems that may impact patient safety Responds to technical or medical information requests from healthcare professionals, JJSV personnel and consumers Produces ad-hoc reports related to product complaints to various global JJSV departments Authors work instructions, reports, and letter templates to standardize departmental processes Leads or participates in developing and modifying quality system processes, projects, and procedures to facilitate compliance Performs other duties assigned as needed Qualifications A minimum of a bachelor’s degree is required A minimum of 2 years of proven experience is required Direct experience supporting complaint handling and adverse event reporting is required Successful collaboration and cross-functional team experience in a matrix organization is required Strong digital literacy and knowledge of various programs such as Microsoft Office, Complaint Handling System, and ERP system is required Knowledge of GDP, 21 CFR Part 820 (QSR), and ISO 13485 (QMS) requirements are required Strong technical and analytical skills are required Ability to travel up to 10% in North America required 2 years of direct experience in Quality Systems within the medical device industry is preferred A degree in Engineering, Sciences, or ophthalmology is preferred Direct experience supporting internal and external audit is preferred Direct experience in addressing CAPA, Non-conformance, and Internal Audit is preferred Clinical experience in the ophthalmology industry is preferred Knowledge of or clinical experience in cataract and laser eye surgeries 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 based on disability.
Primary Location United States-California-Santa Ana-1700 E Saint Andrew Place Other Locations North America-United States-Massachusetts, North America-United States-New Jersey, North America-United States-Ohio, North America-United States-Pennsylvania, North America-United States-Texas, North America-United States-Arizona, North America-United States-Florida-Jacksonville, North America-United States-Texas-Irving, North America-United States-California-Irvine Organization Johnson & Johnson Surgical Vision, Inc (6234) Job Function Quality Requisition ID 2105954753W