RA/QA Auditor (ISO 13485)

Prismatik Dentalcraft is a division of Glidewell Dental

Essential Functions:

• Executes the full lifecycle of audit program(s), including but not limited to developing audit schedule, leading and conducting audits, assessing and reporting results, managing timely responses, and following up on corrections, corrective and/or preventive action items, and verification of effectiveness.
• Conducts audits in a timely manner according to the audit schedule. Reviews containment actions, performs thorough investigations, determines root cause, and develops action and verification of effectiveness plans.
• Interprets recommendations, observations, and findings from audits to ensure corrective actions are appropriate and effective. Informs stakeholders of potential risks.
• Collects and analyzes data to measure effectiveness of audit programs relative to department goals and objectives.
• Partners with process owner to perform verification and assess effectiveness of audit action items.
• Maintains and regularly updates audit tracker to monitor audit status and progress.
• Develops quality and audit metrics and reports, such as PARETO charts and/or control charts, to track audit trends and effectiveness.
• Coordinates and leads stakeholder meetings to ensure visibility into audit statuses and activities. Presents results to stakeholders for alignment and to identify improvement opportunities.
• Participates in supplier audit as part of critical supplier selection and evaluation.
• Presents and distributes internal audit reports including action items from audit results.
• Coordinates and manages onsite audit preparations, including logistics and other audit readiness activities. Participates in third party audits.
• Escalates and supports audit process owner by issuing an audit, Corrective and Preventive Action (CAPA), and/or non-conformance report (NCR) extension request when applicable to prevent a past due record.
• Reviews and approves quality records for compliance, content, completion, accuracy, and relevancy to the subject matter. Ensures records adheres to all applicable procedures, guidance, regulations, and standard requirements.
• Reviews Quality System elements to assess its adherence to the criteria for management and control processes.
• Participates in improvement projects for the Quality Management System (QMS).
• Coordinates and partners with impacted teams to provide guidance on manufacturing processes or quality systems compliance.
• Stays abreast of relevant domestic and international standards and regulations to monitor and ensure conformance.
• Acts as a liaison between internal audit and regulatory agencies, suppliers, and internal teams to facilitate clear and effective communication.
• Performs other related duties and projects as business needs require at direction of management.

Minimum Qualifications:

• Bachelor’s degree in related field, or any equivalent education and/or experience from which comparable knowledge, skills and abilities have been demonstrated/achieved.
• Minimum three (3) years of experience in quality systems within the medical device industry required.
• Minimum four (4) years of experience performing GMP/ISO internal audits required.
• Proficient knowledge of FDA 21CFR 820 Regulations.
• Proficient knowledge of International Organization for Standardization (ISO) 13485 Standard.
• Proficient knowledge of Canadian Medical Devices Regulation (CMDR) SOR/98-282.
• Proficient knowledge of Medical Device Single Audit Program (MDSAP).
• Previous experience developing and adhering to Good Manufacturing Practices (GMPs), Good Laboratory Practices (GLPs), and Standard Operating Procedures (SOPs) required.
• Previous experience in root cause analysis and corrective and preventive action methods required.
• Quality assurance experience in a manufacturing environment is a plus.
• Previous technical writing experience a plus.
• ASQ Certified Quality Auditor, ASQ Certified Biomedical Auditor, ASQ Certified Medical Device Auditor, or IRCA Certification preferred.

Pay range: $75,035 - $95,000/yr

Exact compensation may vary based on skills and experience.

This role is fully onsite at our Irvine, CA campus. Remote or hybrid arrangements are not available.