Sr. Quality Systems Coordinator About Us Orchid’s Arab site in northern Alabama is not far from Huntsville, rated #1 best place to live in the U.S. by U.S. News & World Report 2022-2023. Arab is centrally located to world class recreation and attractions, as well as top‑ranked schools and low cost of living. The Arab, AL site was established in 2007 and joined the Orchid team in 2012. Our 70,000 square foot facility employs approximately 200 team members. We focus primarily on advanced machining of complex instruments for the large joint, spine and trauma markets. Our key products are instruments, implants, and trials. A career at Orchid provides competitive benefits, the ability to take on new responsibilities, and learn and grow in your career. Shift ALA - Shift 1 ($0) (United States of America - Alabama) 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 SOPs, WIs, forms, and training. They serve as the system administrator for QMS applications such as CompliantPro and ComplianceWire. They maintain the Internal Audit schedule and support 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). Manage the CAPA System. Conduct new hire training for Quality disciplines and assist new hires with onboarding training (ComplianceWire). Act 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; support site QMS record compliance activities (e.g., periodic audits of NCMRs, Acceptance Stamps, etc.). Coordinate the nonconformance process and participate in MRB meetings and the auditing of MRB performance. Support Quality and Engineering staff with activities such as product quarantine. Support 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. Process and review document creation/change requests. Assist document owners with writing, editing and training of new and revised procedures. Assist with coordinating, tracking, and recording training. Track and trend quality metrics. Participate in internal and/or external inspections, as required. Verify employee training is current and complete. Assist with Document Control activities (including, but not limited to: closing jobs in Enterprise Resource Planning (ERP) system, scanning documentation, Device History Record (DHR) reviews). Lead 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) 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) 3+ Years of experience with quality systems in a highly regulated industry (i.e. Medical Devices, Aerospace, Pharmaceutical, Food, Automotive, or Nuclear) (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 Physical Demands Must be able to remain in a stationary position – Frequently Must be able to move about the inside of the building – Occasionally Must be able to communicate and exchange information with others – Constantly Must be able to distinguish and detect information such as writing and defects – Constantly What We Offer 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 Additional Requirements 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. At Orchid, we fully support a diverse and inclusive workplace and we are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to, among other things, race, color, religion, sex, sexual orientation, gender identity, national origin, hair type, age, status as a protected veteran, or disability. #J-18808-Ljbffr