The Cardiovascular & Specialty Solutions (CSS) Group, part of the Medical Devices sector within Johnson & Johnson, is recruiting for a Sr. Compliance Auditor to be based out of Plymouth, MN.
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-SurgicalAesthetics, and Reprocessing.
Sterilmed is an FDA-registered medical device manufacturer that provides solutions for hospitals faced with the challenge of improving environmental sustainability and reducing costs without compromising patient care. We are proud to be a part of keeping healthcare accessible and affordable for all by offering services that support device recycling and reprocessed products that deliver cost savings for our customers.
Responsible for development and implementation of quality systems based on business, regulatory and customer requirements.
The Sr. Compliance Auditor is responsible for the management of the internal quality auditing process, assessment of the company’s activities to verify quality system compliance, and management of internal and external standards.
The Sr. Compliance Auditor 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.
· Standards Management: Implement and facilitate process to manage internal and external standards.
· Special Projects and Base Business: Perform special projects as requested
· 4-year college degree (Bachelor’s Degree) or Equivalent in a technical or science-related field or equivalent is required.
· 4 years of auditing experience in a medical device environment are required.
· A Working Knowledge of 21 CFR Part 820, QSR, ISO 13485, SOR 98-282 CMDR (Canada Medical Device Regulations, J-PAL (Japanese), MDD (European) requirements, and knowledge of Brazil GMP and other applicable regulations and standards is required.
· Experience in Medical Device Industry is required.
· Other requirements: 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.
· Master’s Degree or equivalent is preferred, with preferred areas of study being in a Scientific discipline or related Engineering Discipline.
· Previous experience with EtQ is preferred.
· ASQ-Certified Quality Auditor (CQA) or RABQSA-certified Lead Auditor preferred.
· This position is located in Plymouth, MN and may require some travel.