Summary: 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.
Skills: • 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.
Education and/or Experience • Bachelor's Degree in Engineering, Science or related field required. 2-4 years experience in a regulated industry (such as medical device, diagnostics, pharma, and/or aerospace) required. Prior knowledge of QSR and ISO 13485 a plus. Ability to learn quickly and work with precision and accuracy. • Up to 10% travel required.
Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability or protected veteran status.
DSI is the exclusive provider of the Diagnostica Stago Hemostasis product lines in the United States and offers a complete system of coagulation instruments and optimized reagent kits for research as well as for routine analysis. Diagnostica Stago, Inc. is the U.S. subsidiary of Diagnostica Stago, S.A.S. France, a leader in the development and manufacture of Hemostasis products.
A total qualit...y approach plays an integral part in the corporate culture at Stago. We are committed to a better understanding of hemostasis and thrombosis to provide clinical and research laboratories with the most advanced analyzer/reagent systems. In the United States, Diagnostica Stago, Inc. has been servicing the clinical and research hemostasis laboratory community for over 25 years with the same commitment to customers as Diagnostica Stago has maintained in Europe over the last 55 years.