Quality Systems Analyst I

 Requisition ID:                       63234                          Title: Quality Systems Analyst I Division: Arthrex Manufacturing Inc (US02) Location: AMISC-A (US28)

 

 

 

 

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 I for our manufacturing site in Pendleton, SC. The ideal candidate will have a High School Diploma or equivalent required. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

 

Schedule: M-F 8:00am – 4:30pm

 

Essential Duties and Responsibilities:

• 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 standards, 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.
• 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.
• May support other Quality Systems and Regulatory Compliance processes (including NCRs, Product Surveillance, Internal Quality Audits, etc) based on business priorities and departmental workloadSupports various departmental functions during times of short staff or as needed to ensure productivity goals are met. 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.
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• Education and Experience:
• High School Diploma or equivalent required.
• Familiarity with applicable regulations (i.e. ISO 13485) is preferred.
• Previous experience working in a regulated or manufacturing industry and in support of a Quality Management System is preferred.

 

Knowledge and Skill Requirements/Specialized Courses and/or Training:

• Possesses a limited knowledge of Good Documentation Practices (GDP) as required by regulatory and quality standards.
• Knowledge of administrative procedures and computer systems such as word processing, managing files and records, QMS-related Software, and Microsoft Outlook.
• Coordinates Quality Systems Records in regards to timeliness, initiation and closure activities.
• Basic understanding of QMS software as defined in Arthrex QMS policies and procedures with limited understanding of regulatory requirements relate dto the process.
• Provide support for External Audits through planning and limited backroom support.

 

Reasoning Ability:

Ability to define problems, collects data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

 

Language and Communication Skills:

Ability to comprehend and apply language skills to the deg