Quality Systems Analyst II

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 Analyst II who will support the Quality Systems Department to maintain, improve, and monitor the Arthrex Global Quality Management System (QMS), in compliance with FDA QSR, ISO 13485, MDSAP, and all other applicable regulatory requirements.

Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

• Key member of the Quality Systems superuser network.
• Assists business/process owners with the development, revision and review of QMS documents for compliance and completeness.
• Performs and/or supports Quality Systems data trending/monitoring to ensure applicable QMS process requirements and management goals are being met, while promoting high-quality, and a standardized approach across all locations.
  
  Participates in data-driven improvement initiatives and ongoing projects in Quality Systems to assure the Arthrex QMS meets all applicable requirements.
• Supports Change Control activities, and changes within business operations including, but not limited to, scope expansion of QMS activities and software system changes.
• Leads/supports training activities for new and current employees including but not limited to the following:
  Good Documentation Practices, Control of Records, Control of Documents, and utilization of the Document Management System.
• Provides guidance to users of QMS software regarding use and regulatory compliance requirements.
• Maintains knowledge of current regulations and standards affecting the department.
• Effectively interfaces with internal and external customers (including engineering, marketing, regulatory, supply chain, and other departments) to accomplish quality, productivity, and efficiency goals and ensure effective process implementation.
• Supports and/or participates in internal and external QMS audits and inspections as a department representative, including audit preparation, responding to documentation requests, backroom and front room support, and interfacing with auditors and regulatory entities.
• Establishes strategies to manage system workload and supports various departmental functions during times of short staff or as needed to ensure productivity goals are met.
• May support other Quality Systems and Regulatory Compliance processes (including NCRs, Product Surveillance, Internal Quality Audits, etc) based on business priorities and departmental workload Supports various departmental functions during times of short staff or as needed to ensure productivity goals are met.

• Document management activities may include: processing document transactions (new documents, revised documents, withdrawn documents, periodic review, and gap analyses) through the electronic document management system, site record management, external document management, and training of users on system functionality. Higher level roles may serve as system SME, providing higher level oversight and input into system design, improvement, and operation.
• CAPA / NCR management activities may include: record initiation, coordination, and ownership, completing investigations and associated action plans, reporting on activity status and timeliness. Higher level roles may provide higher level oversight and inputs regarding regulatory expectations.
• Change Management activities may include: processing change record transactions in the electronic system, reporting on activity status and timeliness, follow up with record owners, training of users on system functionality, review of Change Management plans and records to ensure compliance. Higher level roles may serve as system SME, providing higher level oversight and inputs regarding regulatory expectations, and providing input into systems design, improvement, and operation.
• Data Collection and Analysis activities include, but not limited to: collecting department process data, analyzing metrics, generating and/or preparing data reports or presentations, identifying trends and their causes, and proposing actions to address trends.
• Audit management activities may include: support of internal audit program through record retrieval, serving as a SME, conducting audits as a qualified auditor, entry and management of internal audit findings, and reporting on activity status and timeliness. External audit support may include backroom set up and support including record retrieval during audits. Developing and executing responses to internal and external audit findings.

• Associates Degree required
• 1+ year experience working in a regulated or manufacturing industry and in support of a Quality Management System

Ability to define problems, collects data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical…