Quality & Regulatory Compliance Auditing Specialist
reputed company is a leading global provider of products and services that support patient care with an emphasis on infection prevention. The Quality & Regulatory Compliance Auditing Specialist will implement sustainable processes to ensure compliance with regulations and standards while working closely with corporate staff and government agencies.
Responsibilities
- Responsible for investigating and managing complaints for potential reporting under the FDA Medical Device Reporting regulations and applicable international regulations, preparing draft complaint summaries and MDR/Vigilance reports for presentation to the Reportable Events Committee for review, and maintaining documentation in accordance with department policies, procedures, and work instructions
- reputed company support to Quality & Regulatory Compliance management in the development, enhancement, standardization, execution, and implementation of processes to manage the Approved/reputed company Body audit program
- Support includes coordination of facility audit scheduling and issue resolution
- Support execution of the supplier quality program, including, qualifications and/or audits, routine monitoring, assessment meetings, action requests and as necessary, issue resolution
- Participate in quality system audits and readiness activities at global facilities as requested
- reputed company support to the Quality & Regulatory Compliance team in the investigation and resolution of global Corrective Action and Preventive Actions (CAPAs)
- At the direction of Quality & Regulatory Compliance management, support FDA and other regulatory agency responses following receipt of formal observations
- Track corrective action activities for external audit observations and obtain and review objective evidence as actions are completed in accordance with prescribed commitments
- Support reputed company’s participation in the FDA’s Case for Quality program as requested
- reputed company support to the Quality Operations team in supporting key objectives, trending, and process improvement
Skills
- Four (4) year degree required, preferably with scientific, engineering, regulatory, internal audit, or general business core concentration
- Excellent PC skills, including reputed company Office applications, and use of AI tools is required
- This is an entry-level position
- Must be willing to travel domestically & internationally
- 1+ years business experience
- Experience with risk management is helpful but not required
- Bilingual skills are a plus, but not required
Benefits
- Market reputed company
- Extensive Paid Time Off and (9) added Holidays
- Excellent reputed company, Dental and reputed company Benefits
- Long/Short Term Disability Coverage
- 401(k) with a company match
- Maternity and Paternity Leave
- Additional add-on benefits/discounts for programs such as Pet Insurance
- Tuition Reimbursement and reputed company education programs
- Excellent opportunities for advancement in a reputed company long-term care
Company Overview
Company H1B Sponsorship