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)
Experience in Quality-Related Work (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) (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
Must be able to remain in a stationary position - Frequently
Must be able to move about the inside of the building - Frequently
Must be able to ascend/descend stairs or ladders - Rarely
Must be able to communicate and exchange information with others - Constantly
Must be able to perform tasks that require repetitive handling/adjusting/inspecting/positioning of items and equipment - Rarely
Must be able to distinguish and detect information such as writing and defects - Occasionally
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
Candidates offered employment may be required to submit to a pre-employment background check and pre-employment drug-screening based on position requirements
Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time
Candidates must be able to provide proof of eligibility to work in the United States through eVerify