Job Title:  Senior Quality Systems Specialist

This is a professional position with responsibilities for elements of the site quality system. The Sr. Quality Systems Specialist is experienced in multiple areas of medical device quality assurance and is capable of applying that experience and in-depth knowledge to proactively drive continuous improvement initiatives and work independently with minimal guidance from management.  Serves as a technical reference and subject matter expert for colleagues with less experience.  This position will provide leadership for improvement projects and will have the ability to solve problems affecting the quality system. 

Major Responsibilities:

Responsible for planning, organizing and conducting duties related to elements of the site quality system including;

• Internal & External Audits
• Corrective & Preventive Action (CAPA)
• Risk Assessments
• Document Control & Record Management
• Quality Agreements
• Training
• Customer Complaints
• Management Reviews
• Validation
• Non-Conformances
• Design Controls
• Maintain and improve the Quality Management System (QMS) to comply with all applicable requirements for medical devices (i.e. 21 CFR 820 Quality System Regulation; ISO 13485:2016; ISO 14971:2019).
• Utilize knowledge and expertise to identify, solve and document problems and risks within the quality system.
• Provide leadership for improvement projects.
• Conduct and support training (i.e. QSR, GMP’s, Internal Auditing, FDA Inspections, Quality Reporting, Customer Complaint Management, Document Control, etc.).
• Serve as a Subject Matter Expert (SME) for colleagues.
• Conduct Internal Audits and support External Audits (i.e. FDA, UL, etc.)
• Support QARA Management in conducting Management Reviews and in developing quality objectives.
• Manage/Support Customer Complaint Management, Internal Audit, Risk Assessment, Document Control and CAPA processes.
• Support data collection, quality report preparation and metric creation/deployment.

Education & Experience:

• Bachelor’s Degree in Science or technical field and 5+ years experience in the Medical Device Industry.
• Strong experience working with a Quality Management System (i.e. Master Control Platform; Qumas Platform, etc.) and its elements.
• Solid experience working in a Class I and Class II Medical Device environment.
• Extensive knowledge of medical device regulations/standards including 21 CFR 820 (QSR) and ISO – 13485:2016.
• Knowledge of ISO 14971:2019 (Risk Management for Medical Devices).
• Experience in Design Controls and conducting training courses.
• Experience hosting and supporting external audits (i.e. FDA Audits, Customer Audits, Corporate Audits, UL, etc.).
• Certifications preferred – i.e. Internal Quality Auditor, Quality Systems/Management, Risk Management.
• Knowledge of Lean/Six Sigma process improvement approaches and techniques.