Quality Systems Administrator

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 employees 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

A BRIEF OVERVIEW
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.

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).
• 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)

EDUCATION QUALIFICATIONS

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

EXPERIENCE QUALIFICATIONS

• 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)

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
• 21 CFR Part 820 Knowledge (Product Quality) - 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 - 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

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.

Orchid Orthopedic Solutions only pays fees for solicited presentations of job seekers submitted through our preferred vendor job board by recruiters, employment agencies, or other parties.