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 services meet established internal and external standards and guidelines. The specialist is responsible for document control and internal audit processes at the North American Distribution Center (NADC). The role also supports the site’s quality system performance, compliance, and continuous improvement efforts, working with cross-functional teams and site leadership. Travel is up to 10%.

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 both in a team and as an individual contributor.
Ability to collaborate with personnel at all levels inside 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.
Demonstrated functional mastery and ability to build relationships across functions and geographies and work with centers of excellence.
Excellent computer skills, including MS Word, Excel, and PowerPoint.
Detail-oriented with a strong, 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 flexibility to handle multifaceted projects alongside day-to-day activities.

Nice To Haves

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

Responsibilities

Manage the lifecycle of QMS documents, including availability, accuracy, distribution, training effectiveness, and periodic review.
Establish, monitor, and respond to metrics on the efficacy and efficiency of the document management system and its ability to support the business.
Develop and monitor the internal corrective and preventive action (CAPA) process.
Provide training and mentorship to nonconformance (NC) owners.
Analyze problems, determine an approach, compile and analyze data, and prepare reports and recommendations.
Support the management review process by developing and generating quality system metrics, producing monthly metric data, and helping prepare QMR presentation slides for selected QMS elements.
Identify opportunities to continuously improve quality system processes.
Identify, implement, and report metrics to site leadership.
Ensure processes needed for the NCE system are documented and controlled.
Maintain effective and efficient quality system processes that ensure compliance with 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 weekly reports and upcoming due dates, running CRB meetings, recording minutes, tracking actions, escalating items to ECRB, 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 developing an improvement roadmap, detailed plan, and communications.
Support the organization and facilitation of FDA, Notified Body, and supplier audits and inspections, including front-room and back-room activities.
Manage the site 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 optimization opportunities to increase effectiveness and efficiency.
Implement corporate strategic initiatives at the site level.
Lead or support Quality Systems projects to support compliance with standards.