The Cardiovascular & Specialty Solutions (CSS) Group, part of the Medical Devices sector within Johnson & Johnson, is recruiting for a Staff Quality Systems Auditor aligned to Biosense Webster located in Irwindale, CA. This position requires 50% travel to Salt Lake City, UT.
The CSS Group consists of six diverse businesses including Acclarent, Advanced Sterilization Products (ASP), Biosense Webster (BWI), Codman Neuro, Mentor, and Sterilmed. The CSS Group serves a diverse base of customers in Ear, Nose and Throat (ENT), Infection Prevention, Electrophysiology (EP), Neurovascular and Neurosurgery, Surgical and Non-Surgical Aesthetics, and Reprocessing.
Biosense Webster is the global leader in the science of diagnosing and treating heart rhythm disorders and one of the fastest-growing businesses within Johnson & Johnson. Learn more about Biosense Webster at www.biosensewebster.com
SUMMARY OF THE JOB
Conducts audits –planned and not planned- to verify the compliance with the government regulations and applicable standards, along with the company policies and procedures. Provides guidance or advice to the organization concerning to the compliance as required.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Under (e.g. limited supervision, general direction, etc.) and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:
· Assures that Quality System Audits comply with QSR/GMP and ISO requirements.
· Conducts internal audits of the Quality System in order to verify the compliance with the government regulations and applicable standards, along with the company policies and procedures. Conducts audits of good laboratory practices (GLP) as required.
· Provides guidance or advice regarding the compliance with applicable standards and regulations.
· Conducts re-audits to deficient aspects and to implemented corrective/preventive actions as needed and required.
· Assigns classifications to internal audit observations and document the audit results in written reports that are distributed and reviewed by the appropriate management.
· Monitors the effectiveness of the corrective actions documented on the observation responses.
· May be lead auditor of auditors’ team, technical experts, trainee auditors, and/or volunteer auditors.
· Reviews appropriateness of responses to audit observations, also, acts as consultant of other areas that are not audited by him/her, providing advice on audit observation response
· Maintains the audit reports files, re-audits files and the responses to the audits performed.
· Escort to external auditors, government agencies representatives or those required by management during the execution of the audit as applicable
· Conducts audits to other J&J sites as required per the management
· Compiles and review metrics related to Compliance and communicate them to the site management and Franchise. Prepares information for the Management Review meetings.
· Participates in the formulation of Policies and Regulatory Procedures in compliance with the standards and applicable local, state and federal regulations through the development of Franchise Documents.
· Keeps updated on government regulations and applicable standards changes through publications, participation in seminaries or collaboration with organizations.
· Responsible for communicating business related issues or opportunities to next management level
· Responsible for ensuring subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition
· Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
· Performs other duties assigned as needed
REQUIRED EDUCATION/TRAINING and/or EXPERIENCE:
· Bachelor’s Degree (BS) in Engineering of a related area, Master Degree (desirable)
· Typically requires 5-7 years plus experience and/or training in the area if has a BS in Engineering;
· Master Degree is preferred with 3+ years’ experience
· Experience working in FDA regulated environment.
REQUIRED KNOWLEDGE, SKILLS, ABILITIES and CERTIFICATIONS/LICENSES: