Quality Systems Manager

Arthrex

13d

About The Position

Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is actively searching for a Quality Systems Manager for our Pendleton, SC manufacturing location. A Bachelor's degree is required (engineering or related discipline preferred). Five years of direct quality experience is also required. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™. Main Objective: The Manager, Manufacturing Quality Systems is responsible for managing, improving, and maintaining the Arthrex manufacturing site Quality System in accordance with the Arthrex Global QMS to ensure compliance to FDA QSR, ISO 13485, and all other applicable regulatory requirements.

Requirements

Bachelor’s degree required, preferably in an Engineering discipline
5 years experience in a medical device company in a quality management and/or quality engineering role required
Strong working knowledge of FDA Quality System Regulation, ISO 13485 and applicable international regulations.
Meets deadlines consistently.
Strong problem-solving skills, initiative and motivation for improvements.
Good project management skills.
Strict attention to detail.
Excellent communication skills are essential.
Proficiency in the use of PC and programs, particularly Excel, Word (or equivalents if changed by the Company), PowerPoint, SAP or similar business software.

Responsibilities

Ensures that the Arthrex Global QMS is supported, maintained, and improved at the site manufacturing level to comply with the most current applicable FDA, ISO and other international regulations. Provides training to relevant personnel as required.
Leads, manages, and develops a staff of Quality Systems dedicated Quality Engineers and Technicians, which may include Specialists and Coordinators, in monitoring and continually improving the site quality system.
Drives the use of and educates others on mechanisms to solve problems that impede compliance and progress.
Proactively evaluates and manages site process audits and corrects when applicable, including the support of Arthrex Global Internal Audits and Site Notified Body Audits.
Ensures that systemic nonconformance trends are monitored, identified, and corrected on a continuous basis.
Leads efforts to identify, implement, and harmonize site and industry best practices.
Develops/defines a process for others to continually improve the site quality system and integrate lessons learned.
Mentors and coaches others in enhancing the Quality System, system’s development and continuous improvement.
Continuously monitors changes to input requirements to ensure that changes are effectively reflected in system requirements and reviewed globally for integration into Global QMS
Leads and facilitates monthly site Quality Reviews, CAPAs, and Scorecard Metrics, including the identification and corrections of negative quality trends.
Support scheduled and unscheduled BSI audits.
Ensure compliance within functional area and support the compliance objectives of the organization as a whole.
Other duties as assigned