20 days old

Senior Quality Systems Analyst - Change Management

Arthrex Manufacturing Inc
Pendleton, SC 29670
  • Job Code
    55278
Requisition ID: 55278 Title: Quality Systems Analyst Sr - Change Management Division: Arthrex Manufacturing Inc (US02) Location: Pendleton, SC

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 Senior Quality Systems Analyst at our manufacturing facility in Pendleton, SC. This position will largely be responsible for engineering change management. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better.

Main Objective:

Support the Quality Systems Department to maintain and improve the Arthrex global Quality Management System (QMS), in compliance with FDA QSR, ISO 13485, MDSAP, and all other applicable regulatory requirements. The Quality System Specialist role may provide focused support for one or more Quality System area, including Document/Records Management, CAPA, NCR, Auditing, or Change Management. Additionally, the Quality System Specialist role may provide backup support for one or more of the other Quality Systems areas for which they do not have primary responsibility.

Essential Duties and Responsibilities

  1. Supports, organizes and coordinates ongoing projects in Quality Systems to assure the Arthrex QMS meets all applicable requirements.
  2. Supports the various Quality System superuser network(s) for the site through coordination of Quality System processes (Document Management, Change Management, CAPA, etc).
  3. Provide guidance to users of QMS software regarding use and regulatory and compliance requirements.
  4. Supports Quality Systems training activities for new and current employees.
  5. Assists business/process owners with the development, revision and review of QMS documents for compliance and completeness.
  6. Supports and/or performs Quality Systems data trending to assure applicable requirements and management goals are being met.
  7. May support site Internal Audit program through completion of the Arthrex qualified QMS auditor process for associate and/or lead auditor.
  8. May support External Audit program through audit preparation, handling of documentation requests, backroom and front room support.

Quality System-specific tasks may include :

  1. Document management activities may include: processing document transactions through the electronic document management system, processing Engineering Change Orders (ECO) for site, site record management, training of users on system functionality, record scanning and filing. Higher level roles may serve as system SME, providing higher level oversight and input into system design and operation.
  2. CAPA / NCR management activities may include: record initiation and coordination, reporting on activity status and timeliness, follow up with record owners, training of users on system functionality, review of CAPA / NCR records to ensure compliance to local requirements. Higher level roles may serve as system SME, providing higher level oversight and inputs regarding regulatory expectations, and providing input into systems design and operation.
  3. 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 and operation.
  4. Audit management activities may include: support of internal audit program through scheduling of audits, entry and management of internal audit findings, reporting on activity status and timeliness. External audit support may include backroom set up and record retrieval during audits. In some cases, Quality System Analysts may be trained to execute audits.

Education/Experience:

  • Bachelor's Degree preferred or 3+ years of experience in a quality systems related role.
  • Working knowledge of FDA's Quality System Regulations and ISO 13485 is preferred.
  • Previous experience working in a regulated or manufacturing industry and in support of a Quality Management System is preferred.

Knowledge & Skills Requirement:

  • Possess a higher level knowledge of Good Documentation Practices (GDP) as required by regulatory and quality standards.
  • Advanced knowledge of administrative procedures and computer systems such as word processing, managing files and records, Excel, Power Point, Documentum, SAP, and Microsoft Outlook.
  • Coordinates Quality Systems Records in regards to timeliness, initiation and closure activities. Collaborate with responsible parties to ensure adequate compliance to Arthrex QMS procedural requirements. Establishes strategies to manage system workload.
  • Key member of the Quality Systems superuser network, providing system feedback and recommendations for systems improvements.
  • Provide guidance to users based on an extensive knowledge of QMS software and a good understanding of regulatory and compliance requirements for the system.
  • Assists business/process owners with the authoring, revision and review of QMS documents for compliance and completeness. May independently author changes to system documents in their area of responsibility.
  • Provide support for External Audits through planning, backroom support and record requests.
  • Effective and timely communication with team and supervisor regarding issues. Demonstrates a working knowledge of effective communication to those in leadership in written and verbal formats.
  • Participates in Quality Systems site and global projects as part of a team to ensure the Arthrex QMS meets all applicable requirements. Assumes leadership roles for project tasks.
  • Assists in collecting and preparing Quality System data for trending purposes to support the compliance to applicable requirements and ensure management goals are met. Does investigation of significant trends for root cause analysis. Interprets trend results.
  • Supports Quality Systems training activities for new and current employees including but not limited to the following: Good Documentation Practices, Document Management System use and Authoring and CAPA/NCR system guidance. Participates in the development of training materials.

All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.





Posted: 2022-09-09 Expires: 2022-10-08
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Senior Quality Systems Analyst - Change Management

Arthrex Manufacturing Inc
Pendleton, SC 29670

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