The Quality Systems Specialist continually improves the Quality Management System through the monitoring of key performance indicators (metrics). S/he is a key contributor to Management Reviews. S/he manages the internal audit program, performs audits, and follows up on audit related corrective actions. The QS Specialist seeks synergies and efficiencies within QMS business practices.
Essential Duties & Responsibilities:
• Manage the internal audit process. Apply independent judgment to developing audit plans, administering internal audits, and assessing the findings. Apply risk-based thinking to audit findings, and recommend risk-reducing corrective actions when audit non-conformances are identified. Assure compliance with 21 CFR 820 through the audit process. Follow up on audit-related corrective actions.
• Develop, improve, track, and report meaningful and actionable metrics for improving the Quality Management System. Determine when actions are required, and make recommendations for procedural improvements.
• Using judgment and analytical thinking, continually challenge QMS processes and recommend improvements for better compliance and efficiency.
• Provide key metrics to Management Review. By analyzing trends, recommend targets, determine if CAPA is required, investigate anomalies, etc. Make recommendations for improvements.
• Responsible for the backroom operations during external audits/inspections (i.e. Backroom manager during FDA inspections). Provide objective evidence for FDA in a timely manner by managing existing backroom resources in a effective way.
• Maintain knowledge and training required to perform internal audits. Train other internal auditors.
• Increase/maintain knowledge of applicable FDA, Health Canada, and ISO laws, standards, and expectations.
• Perform Biennial document reviews. Update SOPs as required through the change control process. Apply process-related thinking to improve QMS activities.
• Perform other Quality Management duties as required.
• Proficiency in MS Office (especially Word, Excel, and PowerPoint). Ability to learn new applications quickly.
• RAC &/or ASQ &/or related professional certifications are a plus (e.g. CQA or CQE).
• Demonstrated knowledge of quality systems, and good communication and analytical skills. Ability to work with and present to multiple levels and functions is required.