Quality Systems Administrator

Orchid Orthopedic Solutions • Arab, AL

1d • Onsite

About The Position

The Quality Systems Administrator (QSA) supports Quality System goals to achieve overall business unit metrics. They are responsible for maintaining the Alabama site's quality documentation system, including SOP's, WI's, forms, and training. They serve as the system administrator for QMS applications such as CompliantPro and ComplianceWire. They maintain the Internal Audit schedule and supports third-party and customer audits as necessary.

Requirements

• High School Or Equivalent (Required)
• Experience in Quality-Related Work (Required)
• Experience using advanced features of Microsoft Excel, Word, and PowerPoint for data analysis and reporting. (Required)

Nice To Haves

• Bachelor (Preferred)
• 3+ Years of experience with quality systems in a highly regulated industry (i.e. Medical Devices, Aerospace, Pharmaceutical, Food, or Nuclear) (Preferred)
• Experience using and maintaining an electronic Quality Management System (eQMS) (Preferred)
• Experience analyzing data to support business, operational, or quality goals and recommending actions based on findings (Preferred)
• Accuracy and Attention to Detail - Working Experience
• Data Analysis Tools - Working Experience
• ISO 9001 (Quality Management) - Basic Knowledge
• Organization - Basic Knowledge
• Computer Knowledge - Working Experience
• 21 CFR Part 820 Knowledge (Product Quality) - Working Experience
• Quality Management - Working Experience
• Communication - Extensive Experience

Responsibilities

• Leverage advanced capabilities in Microsoft Excel for data analysis and reporting (e.g., pivot tables, lookups, formulas, filtering, charting), and in Microsoft Word and PowerPoint to produce clear, accurate, and professional documents and presentations based on those insights.
• Point-of-contact for site eQMS (CompliantPro).
• Conduct new hire training for Quality disciplines and assist new hires with onboarding training (ComplianceWire).
• Supports required audits, including internal, customer/industry driven, registrar/Notified Body, third party, and regulatory.
• Acts as SME/Audit Coordinator for the Internal Audit program, including performing audits, audit management, scheduling/assigning audits at the Alabama site, and facilitating closure of audit findings.
• Responsible for accurate record keeping of production and inspection quality records; supports site QMS record compliance activities (e.g., periodic audits of NCMRs, Acceptance Stamps, etc.).
• Build strong relationships across functions and levels to support Orchid’s culture of quality.
• Comply with all work rules pertaining to safety, health, quality, and Orchid Alabama QMS.
• Processes and reviews document creation/change requests
• Assists document owners with writing, editing and training of new and revised procedures
• Assists with coordinating, tracking, and recording training
• Tracks and trends quality metrics
• Participates in internal and/or external Inspections, as required
• Verifies employee training is current and complete
• Assists with Document Control activities (including, but not limited to: closing jobs in Enterprise Resource Planning (ERP) system, scanning documentation, Device History Record (DHR) reviews)

Benefits

• Opportunity to work in a growing company
• Ability to help people live a longer, more active life
• Comprehensive benefit package
• Ability to work in an organization that values: Integrity First: We do the right thing Teamwork: We are one Orchid Results: Our results matter

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED
• Number of Employees: 5,001-10,000 employees