Ethicon, part of Johnson & Johnson MedTech family of companies, is recruiting for a Staff Regulatory Compliance Specialist, located in Cornelia, GA.
Ethicon, part of the Johnson & Johnson Medical Devices Companies, has made significant contributions to surgery for more than 60 years from creating the first sutures, to revolutionizing surgery with minimally invasive procedures. Our continuing dedication to Shape the Future of Surgery is built on our commitment to help address the world's most pressing health care issues and improve and save more lives. Through Ethicon's surgical technologies and solutions including sutures, staplers, energy devices, trocars and hemostats and our commitment to treat serious medical conditions like obesity and cancer worldwide, we deliver innovation to make a life-changing impact. For more information, visit www.ethicon.com.
The Staff Regulatory Compliance Specialist will lead and maintain the internal audit program to help the site sustain a state of readiness to applicable regulatory requirements.Participates in site internal audits as a team or lead auditor to ensure compliance with all applicable quality system standards and directives in accordance with internal audit schedule. Leads inspection readiness activities and actively participates in conduct of external quality system audits and inspections. Supports preparation of external audit and inspection responses. Serves on cross site project teams consistent with company goals and objectives to improve overall compliance performance to established metrics and requirements. Manages assigned internal and external audit observations to ensure identified gaps are closed in a timely manner.
Prepares, conducts, monitors and reports on audits of all quality system categories to assess compliance to good manufacturing practices, equipment engineering system, and international organization for standardization standards.
Are you interested in joining a diverse team delivering outstanding results to our customers? Apply now for this exciting opportunity!
Key Responsibilities:
• External inspection readiness and associated activities. Support site audit readiness activities to ensure inspection readiness at all times.
• Supports external audits and mock inspections: e.g. Notified Body, Ministry of Health country inspections, FDA, J&J Corporate Audits for site.
• Executes site inspection readiness actions/tools and participates in audit preparation activities (auditor logistics, front room/back room arrangements, identifying/preparing SME's, etc.).
• Assesses the risk and applicability of audit observations from other J&J facilities to determine impact to the site.
• Executes internal audits, as a team or lead auditor, against established internal audit procedures.
• Ensures adequate corrective actions for internal audits, including investigations and corrective action plans, drive on-time completion of observation action plans, perform follow-up with observation owners, and perform effectiveness monitoring and closure.
• Drives compliance and improvement in audit metrics
• Creates reports and communicates performance against metrics to key stakeholders and highlights/communicates adverse trends in metrics, and take risk based action to remediate.
Qualifications
Education:
• A minimum of a Bachelor's degree is required. Focus Degree in Engineering or technical field is preferred.
Experience and Skills:
Required:
• A minimum of 6 years of experience in a FDA regulated industry (pharmaceutical or medical devices) or another highly regulated industry.
• Knowledge of 21CFR 820, 21 CFR 4, ISO 13485/EN 1SO 13485, ISO 14971/EN ISO 14971, European Medical Devices Directive, Canadian Medical Devices Regulations SOR/98-282, ANVISA Technical Regulations of Good Manufacturing Practices of Medicinal Products and In Vitro Diagnostic Products RDC16/2013, Japan Ministry of Health, Labour and Welfare of Japan Ordinance No. 169, Australia Therapeutic Goods (Medical Devices) Regulations.
• Knowledge of Good Manufacturing Practices (GMPs) and Quality System Regulations (QSRs).
• Position requires proven leadership skills in associate involvement and teamwork, initiative, creativity, assertiveness, attention to detail, and excellent interpersonal skills.
• Ability to work under pressure achieving consistently high results in quality, efficiency, and compliance through individual and team efforts.
• Ability to analyze complex data and integrate multi-disciplinary feedback.
• Knowledge of Microsoft Office (Word, Excel, PowerPoint, and Outlook)
Preferred:
• Current Certified Quality Audit (CQA), Certified Biomedical Auditor (CBA) and/or Lead Auditor certification
• Experience leading internal quality system audits
• Previous experience in Quality, Manufacturing or Engineering
• Statistical and analytical problem solving
• Training in Process Excellence/Six Sigma tools and methodologies and Certification
• Experience with Minitab
Other:
• This position may require up to 15% domestic and/or international travel
• This position will be primarily located in Cornelia, GA but will also require onsite support in the Athens, GA facility.
• Excellent verbal and written communication skills in English is required.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com. no requirements Employment Type: OTHER