QMS Specialist III

Position Summary

The Quality Management Systems Specialist 3 supports the development and maintenance of quality programs, systems, processes, and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines. Also, the Quality Systems Specialist 3 is overall responsible for the document control and internal audit processes at the North American Distribution Center (NADC).

Principal Responsibilities

• Manage the document control lifecycle of all QMS documents, including availability of documentation, accuracy, distribution, training effectiveness, and periodic review.
• Manage, establish, monitor, and respond to metrics on the efficacy and efficiency of the document management system and its ability to support the business.
• Manage in developing and monitoring corrective and preventive action (CAPA) process internally.
• Provide training and mentorship to NC owners.
• Analyzes problems, determines approach, compiles and analyzes data, and prepares reports/recommendations.
• Supports the management review process through the development and generation of quality system metrics and generates monthly data for those metrics. Helps management in creating QMR presentation slides for some QMS elements.
• Identify opportunities to continuously improve the quality system processes.
• Responsible for identifying, implementing, and reporting metrics to site leadership.
• Ensure processes needed for the NCE system are documented and controlled.
• Maintain effective, efficient, and cohesive quality system processes which ensure compliance with internal requirements, as well as external (FDA, ISO, etc.) requirements and expectations.
• Develop, implement, and maintain meaningful NC/CAPA metrics to measure the quality system performance.
• Serve as CAPA Champion as needed: Coach and support CAPA Owners to ensure compliance; monitor weekly reports to act on upcoming due dates; run CRB meetings (record minutes, track actions, escalate to ECRB, and archive records); and train new CAPA Owners. Serve as CAPA Owners and Phase Owners as assigned.
• Manage and provide strategic oversight to the local QMS Audit program through creation of an improvement roadmap and detailed plan including communication.
• Support organization and facilitation (front and back room) of FDA, Notified Body, and Supplier audits and inspections.
• Responsible for site External Standards process.
• Partners with Regulatory and/or departments to execute compliance-related strategies.
• Partners with technical teams to ensure the quality system enables success while maintaining compliance.
• Initiate, prioritize, and lead optimization opportunities to increase effectiveness and efficiency.
• Implement corporate strategic initiatives and execute at a site level.

Education / Experience Requirements

• Bachelor’s degree in business, sciences, quality management-related field, or equivalent professional experience or demonstrated equivalent professional experience.
• 5+ years of relevant experience in a medical device environment with Quality Management Systems.
• Ability to work in a cross-functional team environment, manage multitasking, and be disciplined in completing tasks on schedule.
• Experience with regulatory inspections/audits.
• Experience and knowledge of risk management and CAPA systems.
• Certifications (ASQ CQA/ASQ CLMDA / Exemplar Global/ AAMI, etc.) preferred.
• ISO 13485 Lead Auditor Training, preferred.

Specialized Skills / Other Requirements

• Ability to lead cross-functional teams for project execution.
• Effective verbal and written communication.
• Proficient in technical / systems writing and review.
• Possess interpersonal skills to work in a team and as an individual contributor.
• Ability to collaborate with personnel at all levels both within and outside the company.
• Structured and methodical problem-solving approach.
• Understanding of medical device industry quality system design and management.
• Experience with FDA Quality Systems Regulations, ISO 13485, Quality Certificates, GMP, MDSAP, and EU MDR.
• Ability to foster a positive culture of growth, collaboration, and achievement across the organization.
• Lead or support Quality Systems projects to support compliance to standards.
• Creates a culture of inclusion & involvement.
• Demonstrates Functional Mastery and is adept at relationship building across functions and geography to effectively work with and leverage centers of excellence.
• Excellent computer skills (MS Word, Excel, and PowerPoint).
• Detail oriented and strong data driven analytical approach to Quality processes.
• Ability to communicate positively and professionally with employees at all levels of the organization.
• Resourceful and well-organized. High energy level, comfortable performing multifaceted projects in conjunction with day-to-day activities.