Sr. Quality Systems Coordinator

A Brief Overview

The Sr. Quality Systems Coordinator 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.

What You Will Do

• 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).
• Manages the CAPA System.
• Conduct new hire training for Quality disciplines and assist new hires with onboarding training (ComplianceWire).
• 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.).
• Coordinates the nonconformance process and participates in MRB meetings and the auditing of MRB performance.
• Supports Quality and Engineering staff with activities such as product quarantine.
• Supports the Management Review process to ensure ongoing compliance with and effectiveness of the Orchid QMS, which may require preparing the PowerPoint slide deck, meeting minutes, and tracking action items.
• 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)
• Leads CAPAs and audit finding corrections related to the QMS

Education Qualifications

• High School Or Equivalent (Required)
• Bachelor (Preferred)

Experience Qualifications

• 2+ Years of Experience in Quality (Required)
• 3+ Years of experience with quality systems in a highly regulated industry (i.e. Medical Devices, Aerospace, Pharmaceutical, Food, or Nuclear) (Preferred)
• Experience using advanced features of Microsoft Excel, Word, and PowerPoint for data analysis and reporting (Required)
• Experience using and maintaining an electronic Quality Management System (eQMS) (Required)
• Experience analyzing data to support business, operational, or quality goals and recommending actions based on findings (Preferred)

Licenses and Certifications

Microsoft Office Specialist - Certiport, Inc Or similar (Preferred)

Knowledge & Skills That Enable Success

• 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
• Quality Management - Working Experience
• Communication - Extensive Experience