HireDiversity

Fremont, CA, US

PRINCIPAL QUALITY ENGINEER/AUDITOR-7278121011

Description

Cordis Corporation, a member of Johnson & Johnson's Family of Companies, is recruiting for a Principal Quality Systems Engineer/Auditor, to be located in Miami Lakes FL or Fremont, CA.

Cordis is a recognized leader in providing physicians with breakthrough treatment solutions for peripheral vascular disease, a leader in circulatory disease management, interventional cardiology, radiology and electrophysiology products for circulatory disease management.

Over the last 50 years, a deep understanding of the medical marketplace, unrivaled concern for the needs of patients, and high impact technological innovation have made Cordis a strong developer of breakthrough products for interventional medicine, minimally invasive computer-based imaging and electrophysiology. Today, Cordis employees from around the world share a strong commitment to continue our company's groundbreaking work.

The Principal Quality Systems Engineer/Auditor performs planned and unplanned audits for compliance to applicable government regulations and to company policies and procedures. Provides compliance expertise to Quality Assurance, Regulatory Affairs, Clinical Research, Marketing, and Sales organizations. Escalates risks and issue to executive management and supports management review process. Monitors program performance after implementation to prevent reoccurrence issues. Serve as an internal consultant to the observation owners in the areas of failure investigations and root cause analysis and formulating appropriate action plans. Perform cross-site audits as requested by Quality Assurance or management from other sites (West Coast, Miami Lakes, Juarez, etc.). Provides advice and guidance to less seasoned Internal Auditors. Maintains audit files. Represent Cordis at the Sector or Enterprise meetings.

The Principal Quality Systems Engineer/Auditor supports external inspections including any regulatory inspections (FDA, BSI, etc.) and ERC/MD&D sector audits. Report findings of external auditors to management and supports generating written responses to the observations. Assist in formulating regulatory policies and procedures to be followed by company personnel in compliance with local, state, and federal regulations. Maintain current knowledge of regulatory changes through industry publications, seminars, participation in trade organizations, and government meetings.

Qualifications


A Bachelor's degree and 8 or more years of relevant experience in medical device industry is required. Excellent written and verbal communication skills are required. Experience in conducting and managing internal audits is required. Experience with SOP development and working knowledge of GXPs and GMPs is required. In Depth knowledge of Design Control requirements/process and understanding of Design History Files is required. Knowledge of risk management process is required. Hand-on experience in new product development is preferred. Good negotiating skills are preferred. The ability to understand regulatory requirements and translate to actionable items is required. This position will could be based in either Miami Lakes, FL or Fremont, CA. Up to 25% domestic 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-California-Fremont
Other Locations:North America-United States-Florida-Miami Lakes
Organization: Cordis Corporation (6017)