Rhythmlink International is a Columbia, South Carolina-based medical device manufacturer specializing in neurodiagnostic connectivity products used in EEG, EMG, and intraoperative neuromonitoring (IONM). The company supports manufacturing across Columbia, Costa Rica, and Shenzhen, China, giving its engineering team the opportunity to work across a truly global operation.

Rhythmlink has built a highly regarded workplace culture, including 15 years of recognition as a Best Place to Work in South Carolina. This Senior Quality Engineer will join a collaborative quality engineering environment with meaningful exposure to risk management, supplier quality, sterilization, quality systems, and global cross-functional work.

Position

The Senior Quality Engineer is responsible for the coordination and maintenance of the Rhythmlink Quality Engineering Program. Through established standards and customer-specific requirements, this role is responsible for meeting company objectives, facilitating continuous improvement, and achieving total customer satisfaction. The priority areas of focus include the application of risk management, supplier quality, sterilization, internal process quality, verification and validation activities, and internal/external customer experience. This position serves as an engaged and trusted quality engineering expert in the organization. Success in this role is measured by compliance verified through audits, favorable KPIs, and lower cost of poor quality. Key deliverables to ensure success are listed below in the essential functions.

Essential Functions

Risk Management

• Manages and monitors the product and process risk management program per ISO 14971 to ensure adherence to established procedures and regulatory standards.
• Supports post-market surveillance activities to drive a risk-based Quality Management System (QMS).

Supplier Quality

• Manages and monitors supplier quality programs, including supplier qualifications to ensure adherence to established procedures and regulatory standards.
• Collaborate and/or lead cross-functional teams to drive supplier compliance and manage supplier KPIs.

Sterilization

• Serves as Rhythmlink’s subject matter expert for sterilization and cleanroom standards.
• Manages and monitors Rhythmlink’s sterilization program, including management of sterilization facilities (gamma and EO) and product families (validations, testing, requalification, and product adoptions).
• Responsible for the management and control of cleanroom and controlled work environments.
• Manages the calibration and preventative maintenance program.

Quality Systems

• Works closely with quality management regarding planning and coordination of all activities that impact or could potentially impact the QMS.
• Monitors quality assurance objectives and key performance indicators complementary to company policies and goals and consistently strives to improve metrics.
• Presents key performance indicators through periodic regulatory communication and management review.
• Provides support for process-related corrective action implementation, quality-related production documentation, studies, and activities necessary to increase control and lower the cost of poor quality.
• Resolves CAPAs within required timelines in areas of responsibility.
• Maintains product families as state of the art through the application of new and revised technical standards.
• Support customer complaint investigations, by providing technical expertise during root cause analysis and sample review.
• Review and approve design control, manufacturing, quality, engineering, and validation/ qualification documents for conformance to departmental procedures and risk management.
• Review product labels/labeling, ensuring technical accuracy, alignment with the risk profile of the device, and compliance with US and international regulatory requirements and standards.
• Provide technical documentation to internal and external customers, including but not limited to RoHS/REACH, hazardous materials, MSDS, and regulatory technical summaries.
• Understand quality system requirements of customers, FDA, ISO 13485, MDSAP, and other regulatory agencies, and use quality tools to improve processes and products within those standards.
• Serve as subject matter expert in internal/external regulatory and customer audits.

Knowledge, Skills, and Abilities

• Strong knowledge of ISO 13485, 21 CFR 820 and MDSAP
• Strong knowledge of Sterilization, Ethylene Oxide, and Gamma ISO 11135 and ISO 11137
• Strong knowledge of Change Control procedures and practices
• Ability to self-prioritize, remain self-motivated and drive favorable KPI’s
• Working knowledge of statistics,
• Ability to manage many projects without loss of accuracy or sense of urgency on any
• Strong aptitude for reading, understanding, communicating, and applying complex and detailed guidelines and requirements from multiple agencies in multiple countries
• Unwavering attention to detail.
• Ability to work and influence people in various levels, departments, and functions in the company
• Strong verbal and written communication skills
• Ability to maintain a professional, courteous, and positive demeanor in all situations

Education, Training and Experience

• Bachelor’s degree in engineering and 5 years’ experience in the medical device industry. Experience should demonstrate a progression in scope of responsibility.

or

• Associates degree in engineering and 10 years’ experience in the medical device industry. Experience should demonstrate a progression in scope of responsibility.

Preferred Experience

• Certified Quality Engineer
• Certified Quality Improvement Associate
• Certified Quality Auditor
• Certified Project Manager

This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Additional responsibilities and duties will be required depending on a variety of factors.