QMS Specialist III

Teleflex•Olive Branch, MS

About The Position

The Quality Management Systems Specialist III supports the development and maintenance of quality programs, systems, processes, and procedures to ensure policy compliance and that the performance and quality of services conform to established internal and external standards and guidelines. The role is responsible for document control and internal audit processes at the North American Distribution Center (NADC), while supporting compliance with applicable requirements and continuous improvement of the quality system.

Requirements

Bachelor’s degree in business, sciences, a quality management-related field, or equivalent professional experience or demonstrated equivalent professional experience.
At least 5 years of relevant experience in a medical device environment with Quality Management Systems.
Ability to work in a cross-functional team environment, manage multiple tasks, and complete work on schedule.
Experience with regulatory inspections and audits.
Experience and knowledge of risk management and CAPA systems.
Ability to lead cross-functional teams for project execution.
Effective verbal and written communication skills.
Proficiency in technical and systems writing and review.
Interpersonal skills to work in a team and as an individual contributor.
Ability to collaborate with personnel at all levels 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.
Ability to create a culture of inclusion and involvement.
Functional mastery and relationship-building skills across functions and geographies.
Strong computer skills, including MS Word, Excel, and PowerPoint.
Detail-oriented, data-driven analytical approach to quality processes.
Ability to communicate positively and professionally with employees at all organizational levels.
Resourceful and well-organized, with the energy and ability to perform multifaceted projects alongside day-to-day activities.

Nice To Haves

Certifications such as ASQ CQA, ASQ CLMDA, Exemplar Global, or AAMI.
ISO 13485 Lead Auditor Training.

Responsibilities

Manage the lifecycle of QMS documents, including availability, accuracy, distribution, training effectiveness, and periodic review.
Monitor and report metrics on the effectiveness and efficiency of the document management system.
Develop and monitor the internal corrective and preventive action (CAPA) process.
Provide training and mentorship to nonconformance (NC) owners.
Analyze problems and data, determine approaches, and prepare reports and recommendations.
Support management reviews by developing and generating quality-system metrics and monthly data, and help prepare presentation slides for selected QMS elements.
Identify opportunities to continuously improve quality-system processes.
Identify, implement, and report metrics to site leadership.
Ensure processes required for the NCE system are documented and controlled.
Maintain cohesive quality-system processes that meet internal requirements and external requirements and expectations, including FDA and ISO requirements.
Develop, implement, and maintain NC/CAPA metrics to measure quality-system performance.
Serve as CAPA Champion as needed by coaching and supporting CAPA owners, monitoring due dates, running CRB meetings, tracking and escalating actions, archiving records, and training new CAPA owners.
Serve as CAPA owner and phase owner when assigned.
Manage and provide strategic oversight of the local QMS audit program, including creating an improvement roadmap and detailed plan.
Support the organization and facilitation of FDA, Notified Body, and supplier audits and inspections, including front-room and back-room activities.
Manage the site's External Standards process.
Partner with Regulatory and other departments to execute compliance-related strategies.
Partner with technical teams to ensure the quality system enables success while maintaining compliance.
Initiate, prioritize, and lead opportunities to improve effectiveness and efficiency.
Implement corporate strategic initiatives at the site level.
Lead or support Quality Systems projects that support compliance with standards.