The Role of the Lead Auditor, Quality Systems (Ladder) is to conduct audits of the CONMED Quality Management System to determine conformance to various regulations and standards (FDA QSR, ISO 13485, MDR, CMDR, State, Local Regulations and any other quality system or compliance requirements, etc.). The Lead Auditor, QS will assist in identifying audit findings of the Quality Management System and communicate them to area management. The incumbent may work independently or as part of an audit team. The Lead Auditor, QS will be responsible for developing an annual audit schedule, develop specific audit plans, and document and communicate the results of the audit. Incumbent will work with representatives from audited areas in resolving and correcting identified issues and to participate in audits of other CONMED Divisions. The incumbent will maintain currency with all appropriate guidelines, domestic and international quality system regulations or standards that apply to CONMED. Will act as liaison with external agency, customer/international auditors that visit CONMED. Works with minimal direction.
Duties and Responsibilities:
- Complete unbiased and independent compliance audits of the company's quality systems as required through the review of quality system documents, quality records, and interviews of personnel according to applicable standards and regulations.
- Communicate audit findings to area management accurately and in sufficient detail to allow for effective corrective/preventive action.
- Develop an annual internal audit schedule covering all required departments of the CONMED Quality System and covering all appropriate sections of the QSR and ISO13485.
- Develop and maintain monthly compliance measurements for management.
- Train internal auditors within the company as necessary.
- Document and maintain responses with management input to audits conducted by the US FDA and Notified Body.
- Participate in product quality councils and quality system review board meetings/team meetings as required.
- Provide training and instructional guidance for employees in QSRs, ISO Quality Standards and other topics as required.
- Other assignments as directed by immediate Supervisor such as coordinate product ship hold and/or product recalls, the preparation of recall data, customer communication letters, recall strategies, international notifications, inventory analysis, FDA correspondence, follow up and closure.
Travel up to 25% may be required.
Work Experience Requirements:
- Preferred but not required-Internal auditor certification for medical device industry, CQA or lead Assessor Training.
- Must be organized, detail oriented and able to handle multiple projects at once.
- Must have excellent interpersonal, verbal and writing skills in dealing with external customers, sales representatives, senior management, and outside government officials.
- BS degree in engineering, chemistry, sciences or equivalent or experience working in quality system manufacturing environment.
- Knowledge of QSRs, European Union Directives, ISO 13485 and related International Medical Device regulations and/or guidelines preferred.