Quality Analyst

Quality System Analyst

Cadrex is searching for a Quality System Analyst to be responsible for the administration, configuration, deployment, testing, and continuous optimization of the enterprise Electronic Quality Management System (eQMS), specifically Octave Reliance. This cross-functional role bridges the gap between operational quality management goals and enterprise technical platforms. The Analyst collaborates directly with engineering, quality, operations, and supply chain teams to translate global quality policies into automated, auditable, and highly efficient system workflows.

Key Responsibilities

• Manage day-to-day administrative operations, user provisioning, security profiles, and access controls within the Octave Reliance environment.
• Configure out-of-the-box and custom modules using Reliance tools to optimize key quality processes.
• Troubleshoot platform performance issues, manage system updates, and interface directly with vendor technical support when necessary.
• Partner with cross-functional business units to gather, document, and analyze technical requirements for system enhancements.
• Map, build, and refine specialized workflows for CAPA (Corrective Action Preventive Action), Non-Conformance, Complaint Handling, Audits, Change Management, and Training matrices.
• Ensure that system modifications reduce operational friction while maintaining data integrity.
• Author, review, and execute User Acceptance Testing (UAT) scripts, Installation Qualifications (IQ), Operational Qualifications (OQ), and Performance Qualifications (PQ).
• Maintain comprehensive verification test cases to ensure any software patches, updates, or custom configurations do not compromise system stability.
• Document software defects, track resolutions, and manage pre-and-post deployment validation logs.
• Guarantee that all electronic records and system workflows strictly align with global standard protocols, including ISO 9001, AS9100, ISO 13485 and FDA 21 CFR Part 11.
• Maintain the eQMS in an "audit-ready" state for external regulatory inspections, registrar audits, and customer evaluations.
• Participate as a technical subject matter expert during corporate audits to demonstrate system control, validation tracking, and electronic signature compliance.
• Draft, update, and control comprehensive Standard Operating Procedures (SOPs) and technical system manuals.
• Develop training curricula and lead interactive technical onboarding sessions for new system users and plant administrators.

Preferred Qualifications

• Minimum 2 years of direct exposure configuring, administering, or developing backend workflows within Octave Reliance.
• Practical competence writing Python, JavaScript, or SQL Server queries to implement custom solution attributes, business rules, or handle data migrations.
• Ability to multi-task, work independently and in teams to identify and tackle problems enthusiastically and clearly identify key issues of importance for team resolution.
• Must possess strong interpersonal and communication, written and verbal, skills, including bridging communication between operations and finance community.

Education

• Associate's degree in computer science, Management Information Systems (MIS), Quality Management, or a related business/technical field.

Location

• Remote

Schedule

• M-F

Work Environment

• While performing the duties of this job, the employee is frequently exposed to work near moving mechanical parts and vibration. The employee is occasionally exposed to the risk of electrical shock. The noise level in the work environment is usually moderate and occasionally loud.

Physical Demands

• While performing the duties of this job, the employee is regularly required to stand, sit, use hands and fingers, handle or feel, and talk or hear. The employee is occasionally required to sit; climb or balance; stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, color vision, depth perception and ability to adjust focus.

CadreX's Core Values

• Safety first, rising to the challenge, collaboration, accountability, and doing the right thing

Total Compensation Includes

• Health/dental/vision coverage
• Employer-paid and supplemental life insurance
• Short- and long-term disability insurance
• Generous paid time off and holiday pay
• Monthly remote work stipend (for remote employees who qualify)
• 401(k) investment plan, with an employer match of up to 4%
• Education support program
• Safety eyeglasses/shoe reimbursement
• Referral bonuses
• Bonus plan for all full-time employees

Cadrex provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

Salary Description $71k - $92.5k