The Cardiovascular & Specialty Solutions (CSS) Group, part of the Medical Devices sector within Johnson & Johnson, is recruiting for a Senior Compliance Manager aligned to Advanced Sterilization Products (ASP), division of Ethicon, Inc., a Johnson & Johnson company, located in Irvine, CA.
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.
Advanced Sterilization Products (ASP), division of Ethicon, Inc., a Johnson & Johnson company, truly makes a difference by Protecting Lives against Infection. ASP has been innovating since 1987 to help healthcare facilities protect patients with best-in-class infection prevention solutions. Learn more about Advanced Sterilization Products at www.aspjj.com/us
The Sr. Compliance Manager is responsible for the management of the internal quality auditing process and assessment of the company’s activities to verify quality system compliance.
Duties and Responsibilities:
The Sr. Compliance Manager will collaborate with business partners to ensure compliance to all regulatory and standard requirements. Specific areas of focus will be:
· 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 Sr. 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.
· Perform special projects as requested
· Perform other work-related duties as assigned by the manager of the role.
Required qualifications for the Sr. Compliance Auditor include:
· a Bachelor’s degree in a technical or science-related field or equivalent required;
· 4 years of experience in medical device manufacturing industry with a strong knowledge of 21 CFR 820, ISO 13485, Medical Device Directive, and other applicable regulations and standards required;
· 5 years of auditing experience in a medical device environment required;
· ASQ-Certified Quality Auditor (CQA) or RABQSA-certified Lead Auditor preferred;
· proven leadership, teamwork, collaboration and influencing skills required;
· demonstrated initiative and assertiveness required;
· strong project management skills required;
· strong computer skills and use of software application(s), including MS Windows, MS Office (Word, Excel, PowerPoint) are required;
· strong written and oral communication skills are required.
· Previous experience with EtQ is preferred.
· CQE or CQA is preferred.
· This position is located in Irvine and may require travel.