HireDiversity

Somerville, NJ, US

Supplier Quality Staff Engineer/Auditor (1 of 2)-8780130116

Description

Ethicon Surgical Care, a member of the Johnson & Johnson Family of Companies, is recruiting a Supplier Quality Staff Engineer/Auditor (1 of 2). The preferred location for this position is Somerville, NJ, however this position can also be located at any other MD&D location globally.

The Ethicon Surgical Care business offers a broad range of products, platforms and technologies-including sutures, surgical staplers, clip appliers, trocars and synthetic mesh devices-that are used in a wide variety of minimally invasive and open surgical procedures. Specialties include support for treatment of colorectal and thoracic conditions, women's health conditions, hernias, cancer and obesity. The Ethicon Surgical Care business combines products and services of two market leading legacy companies, both with long histories of medical innovation. Ethicon, Inc. based in Somerville, New Jersey, was founded more than 80 years ago as a pioneer in suture development and manufacturing, helping to transform the safety and electiveness of open surgery. Ethicon Endo-Surgery, Inc. was created 20 years ago in Cincinnati, Ohio, developing innovative devices that have driven the revolutionary shift from open to minimally invasive surgery that continues to lead the industry today.

The Supplier Quality Staff Engineer/Auditor performs planned and unplanned Supplier or External Manufacturer (EM) audits to verify compliance to applicable government regulations, standards and to company policies and procedures. Provides supplier or EM compliance expertise to the organization as required.

The Supplier Quality Staff Engineer/Auditor assures that the supplier or EM quality system audit function complies with QSR/GMP, ISO and other regulatory requirements. Performs audits of suppliers or EMs for compliance to applicable government regulations, material specifications, to international standards and to company policies and procedures. Performs supplier or EM re-audits of deficient matters and corrective actions, as needed and required. Assigns classifications and documents supplier or EM audit results in written audit reports that are distributed and reviewed by appropriate management. Monitors the effectiveness of supplier or EM corrective action responses. Can serve as lead auditor, leading a team of auditors, technical experts, auditors-in-training and/or volunteer auditors. Maintains files containing reports of supplier or EM audits, re-audits and corrective action responses. Provides direction and guidance to auditors in training and/or volunteer auditors.

This individual collects and reviews supplier or EM audit metrics and communicates to site and worldwide management. Generates data for management reviews. Assists in formulating supplier or EM procedures to be followed by the auditing group. Stays 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.

Qualifications


A Bachelor's degree (or equivalent education) in a related science or engineering field of study and a minimum of 7 years of related experience OR a Master's degree (or equivalent education) and a minimum of 5 years of related experience OR a Ph.D. (or equivalent education) and a minimum of 3 years of related experience is required. Proven ability to conduct and manage audits is preferred. Computer Systems Validation experience is preferred. Expertise in dealing with the Food & Drug Administration and other regulatory bodies is preferred. Knowledge and skills in quality-related methods and techniques including auditing principles and techniques, quality terminology, as well as quality management principles and quality management tools and their applications are preferred.

Good written and oral English communication skills are required. Expert understanding of FDA CFR Part 820, Part 11, and ISO 13485 regulations is required. Six Sigma, Lean, ISO lead auditor, or ASQ CQA certification and training is preferred.

The preferred location for this position is Somerville, NJ, however this position can be located at any MD&D location globally. Up to approximately 40% domestic and international travel may be required.

BE VITAL in your career. Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.

Primary Location:North America-United States-New Jersey-Somerville
Other Locations:Europe/Middle East/Africa, Latin America-Mexico
Organization: Ethicon Inc. (6045)