Principal Quality Auditor - (Job Number: 0800530)

Principal Quality Auditor - (Job Number: 0800530) DescriptionCordis Corporation, a member of Johnson & Johnson's Family of Companies, is recruiting for a Principal Supplier Quality Auditor. Ground breaking, life changing careers that reward the power of ideas and innovation. For more than 40 years, Cordis Corporation has pioneered less invasive treatments for vascular disease. Technological innovation and a deep understanding of the medical marketplace and the needs of patients have made Cordis the world's leading developer and manufacturer of breakthrough products for interventional medicine, minimally invasive computer-based imaging, and electrophysiology. Today, over 7,000 Cordis employees worldwide share a strong commitment to continue the Company's groundbreaking work in the fight against vascular disease. Cordis Corporation offers tremendous opportunities and world-class resources. Our decentralized structure provides the feel of a small-company environment with big-company impact. We are focused on developing leaders with a broad base of business and cultural skills, along with a strong commitment to the values expressed in Our Credo. By choosing Cordis Corporation, you are choosing to positively impact the lives of millions of people each year. The Principal Quality Auditor assures that the quality system audit function complies with QSR/GMP, ISO and other regulatory requirements. Performs audits for compliance to applicable government regulations, material specifications, to international standards and to company policies and procedures. Performs re'audits of deficient matters and corrective actions, as needed and required. Assigns classifications and documents results in written audit reports that are distributed and reviewed by appropriate management. Monitors the effectiveness of supplier corrective action responses. Can serves as lead auditor, leading a team of auditors, technical experts, auditors-in-training and/or volunteer auditors. Maintains files containing reports of audits, re'audits and corrective action responses. Provides direction and guidance to auditors in training and/or volunteer auditors. Collects and reviews supplier audit metrics and communicates to site and worldwide management. Generates data for management reviews. Assists in formulating procedures to be followed by auditing group. Maintains abreast of regulatory changes through industry publications, seminars, participation in trade organizations, and government meetings. Responsible for following all company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition. This role is for a self-motivated individual who craves the ability to be autonomous and manage their daily schedule and responsibilities accordingly. They will be the face of J & J to the FDA, internal customers as well as external suppliers. BS in a related field of study; and 14 or more years of related experience and/or training; or MS with 12 or more years; or Ph.D. with 9 or more years; or equivalent combination of education and experience. Proven ability to conduct audits. Microbiology or Computer Systems Validation experience preferred. Extensive expertise dealing with the Food & Drug Administration is preferred. Knowledge and skills in quality-related methods and techniques including auditing principles and techniques, quality terminology, quality management principles and their applications and quality management tools and their applications are required. CQA certification is required. ISO Lead Assessor certification is preferred. Ten years of Auditing experience is required. The position will require approximately 10% travel both domestically and internationally. Internal Audit experience is required. Good written and oral English communication skills are required. Ability to read, analyze and interpret scientific and technical journals, financial reports, and legal documents. Ability to select, manage and direct a team during an audit. Ability to respond to common inquiries, regulatory agencies, or members of the business community is required. Ability to write speeches and articles for publication that conform to prescribe style and format is required. Ability to effectively present information to top management, public groups, and/or boards of directors is required. Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to effectively interface with governmental and independent auditors is required. Apply Now