The Compliance and Audit Specialist plays a pivotal role in continuously monitoring and improving the Quality Management System through leading projects, auditing, reporting metrics, and implementing industry best practices. Among other duties, they manage the internal audit program, lead QMS projects, perform internal and supplier audits, interact with regulators and auditing organizations, support CAPA investigations, write procedures, present data to all levels of the organization, act as a trainer, and are proficient users of several software platforms. The Compliance and Audit Specialist is SNA's Deputy Management Representative.
Essential Duties & Responsibilities:
Acts as the Deputy Management Representative in the Director's absence.
Acts as ISO 13485 SME. Leads teams that will make significant improvements, changes, and additions to the QMS.
Manages QMS projects and influences cross-functional team members.
Manages the internal audit program. Trains new auditors. Applies independent judgment to developing audit plans, administering internal audits, and assessing the findings. Applies risk-based thinking to audit findings,and recommends risk-reducing corrective actions when audit non-conformities are identified. Assures compliance with SNA procedures, 21 CFR 820, SOR/98-282, and ISO 13485 through the internal audit program. Follows up on audit-related corrective actions.
Develops, improves, tracks, and reports meaningful and actionable metrics for the Management Review Process.
Determines when actions are required and makes recommendations for procedural improvements. Determines if CAPA actions are required.
Helps facilitate third party audits and inspections by representing Stago North America with face-to-face interaction with regulators and auditors in the audit Front Room.
Is a highly proficient user of key systems (e.g. CRM, Open Text, Intraqual Dynamic). Identifies opportunities for improvement and makes recommendations to the Data Management teams in Headquarters.
Maintains knowledge and training required to perform internal audits. Trains other internal auditors.
Performs supplier reviews and supplier audits as necessary and appropriate.
Leads annual process reviews to assure that risk management documents remain current. Reports the outcome to upper management as part of the Management Review Process.
Delivers training and presents data and project status information to all levels of the organization.
Attends monthly validation meetings with HQ.
Prepares data package for Management Review Meetings.
Performs other Quality Management duties as required.
Education and/or Experience:
Bachelor’s degree in Engineering, Science, or related field required (Master’s degree preferred).
Three to Five years progressive experience in medical device quality or quality management systems required (or Master’s degree + 3 Years' experience).
Demonstrated proficiency in internal and/or external QMS auditing.
Knowledge in medical device and FDA Regulations is required. ISO 13485 experience is preferred.
Proficiency in MS Office (especially Word, Excel, Project, and Powerpoint). Demonstrated ability to analyze and present Key Performance Indicators. Ability to learn new applications quickly.
ASQ (or similar) professional certifications a plus (e.g. Certified Quality Engineer or Auditor).
Up to 10% travel required.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, citizenship, disability or protected veteran status.
Diagnostica Stago, Inc., (DSI) is an industry leader in the science of hemostasis and thrombosis. Stago provides the total commitment of global resources and responsiveness, coupled with cutting edge technology and reliability. DSI is dedicated to continually developing and providing the very best hemostasis products, technical support, and services.