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Staff Compliance Auditor
Miami, Florida; Fremont, California; Miramar, Florida
Requisition ID: 3268180209
Johnson & Johnson’s Neurovascular Division (CNV), a member of the Medical Device group within Cardiovascular & Specialty Solutions (CSS) is recruiting for a Staff Compliance Auditor. The position can be located in either Fremont, CA or Miami or Miramar, FL locations.
The Cardiovascular & Specialty Solutions (CSS) Group consists of six diverse businesses aside from Neurovascular which serve a diverse base of customers in Ear, Nose and Throat (ENT), Infection Prevention, Electrophysiology (EP), Surgical and Non-Surgical Aesthetics, and Reprocessing.
Johnson & Johnson’s Neurovascular (CNV) Division is one of the leaders in the medical device industry. Our implants and instruments are used by interventional neuroradiologists, neurosurgeons and neurologists, to treat patients with conditions resulting from hemorrhagic and ischemic stroke. Our environment is entrepreneurial, learning-driven, and is as challenging as it is rewarding. We are one of the fastest growing businesses within Johnson & Johnson.
The Staff Compliance Auditor is responsible for the management of the internal quality auditing process and assessment of the company’s activities to verify quality system compliance.
Internal Audits: Establishes, evaluates and maintains the internal audit program that ensures quality management systems are operating in compliance; develops and manages audit plans; conducts audits, develops metrics and compiles data on auditing results, issues or trends and corrective actions and presents to senior management; and develops and delivers required training. Research emerging regulatory trends and changes in regulations and standards to incorporate into the business to ensure ongoing compliance to these requirements.
The Staff Compliance Auditor also coordinates and supports requests for directed audits, received from senior management and other customer/business partner groups; supports inspection readiness, external inspections, and other quality and compliance projects; and performs other assigned duties, as needed.
- A minimum of a Bachelors’ degree is required
- 6+ years of experience in Pharmaceutical or medical device manufacturing industry with a strong knowledge of 21 CFR 820, ISO 13485, Medical Device Directive, and other applicable regulations and standards
- 5+ years of auditing experience in a medical device or Pharmaceutical environment
- ASQ-Certified Quality Auditor (CQA) or RABQSA-certified Lead Auditor preferred
- Proven leadership, teamwork, collaboration and influencing skills
- Demonstrated initiative and assertiveness
- Strong project management skills
- Strong computer skills and use of software application(s), including MS Windows, MS Office (Word, Excel, PowerPoint)
- Strong written and oral communication skills
- Previous experience with EtQ is preferred
- Travel up to 20%, both domestic and international
Do you strive to join an outstanding team that is dynamic and ever-changing? Is career growth and opportunity appealing to you? Apply to this opportunity today.
Johnson & JohnsonFamily of Companies are equal opportunityemployers, and all qualified applicants willreceive consideration for employment withoutregard to race, color, religion, sex,sexual orientation, gender identity, geneticinformation, national origin, protected veteranstatus, disability status, or any othercharacteristic protected by law.
North America-United States-Florida-Miramar, North America-United States-California-Fremont
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