Position Summary
The Quality Systems Specialist is responsible for supporting the company’s Quality Management System across FDA-regulated IVD/product activities and CLIA-certified laboratory operations. This role helps maintain compliant, organized, and inspection-ready quality systems, including document control, training, CAPA, deviations, complaints, nonconformances, audits, change control, supplier quality, validation records, and laboratory quality documentation.
The ideal candidate will have hands-on experience working in a regulated quality environment, preferably within IVD, medical device, diagnostics, biotechnology, or clinical laboratory operations. This position requires strong attention to detail, excellent documentation practices, and the ability to work cross-functionally with Quality, Regulatory Affairs, Laboratory Operations, Manufacturing, R&D, Product, and Operations teams.
Experience with FDA quality system requirements is important, and experience with CLIA, CAP, and state laboratory quality requirements is highly preferred.
Key ResponsibilitiesQuality System Support
· Support implementation, maintenance, and continuous improvement of the company’s Quality Management System.
· Assist with quality system processes including document control, training, CAPA, deviations, nonconformances, complaints, change control, audits, and management review.
· Ensure quality records are complete, accurate, properly approved, and maintained in accordance with company procedures and regulatory requirements.
· Support quality metric tracking, trending, reporting, and follow-up activities.
· Help maintain inspection-ready quality files, logs, trackers, and records.
Document Control
· Manage controlled documents, including SOPs, work instructions, forms, templates, policies, protocols, reports, and quality records.
· Coordinate document creation, routing, review, approval, release, revision, obsolescence, and archival.
· Ensure documents are accurate, current, properly formatted, and aligned with company procedures.
· Maintain document control logs and ensure employees have access to current approved documents.
· Support periodic document review and updates.
Training System
· Maintain the employee training system and training records.
· Assign training based on job roles, procedures, regulatory requirements, and process changes.
· Track training completion and follow up on overdue training.
· Support onboarding training for new employees.
· Ensure training records are complete, accurate, and audit-ready.
CAPA, Deviations, and Nonconformance Support
· Support documentation, investigation, tracking, and closure of CAPAs, deviations, nonconformances, complaints, and quality events.
· Assist process owners with root cause analysis, corrective actions, preventive actions, and effectiveness checks.
· Ensure quality events are documented clearly and completed within required timelines.
· Maintain CAPA, deviation, complaint, and nonconformance logs.
· Support trending of recurring issues and escalation of quality concerns.
Change Control
· Support change control activities for quality system procedures, laboratory processes, product design, labeling, suppliers, materials, software, equipment, and manufacturing processes.
· Help coordinate change assessments, approvals, implementation tasks, training, and effectiveness checks.
· Ensure changes are properly documented and supported by appropriate risk, regulatory, validation, and operational assessments.
FDA / IVD Quality Support
· Support quality activities related to FDA-regulated IVD or medical device products.
· Assist with quality records related to design controls, risk management, verification and validation, design transfer, supplier controls, manufacturing records, labeling, and product release.
· Help maintain Design History File, Device Master Record, Device History Record, validation files, risk files, and related quality documentation.
· Support preparation for FDA inspections, ISO audits, customer audits, and partner audits.
· Assist with complaint handling, product quality trending, and post-market quality documentation.
CLIA Laboratory Quality Support
· Support quality systems for CLIA-certified laboratory operations.
· Assist with laboratory document control, training, competency records, proficiency testing records, equipment maintenance records, temperature logs, reagent logs, validation/verification records, quality control records, and corrective action documentation.
· Help ensure laboratory records are complete, accurate, traceable, and inspection-ready.
· Support laboratory quality event investigations, including specimen issues, testing errors, workflow deviations, corrected reports, and customer or provider complaints.
· Assist with CLIA, CAP, and state inspection preparation and follow-up activities.
· Work closely with the Laboratory Director, Technical Supervisor, General Supervisor, Quality leadership, and laboratory personnel to maintain compliance.
Audits and Inspection Readiness
· Support internal audits of quality system, laboratory, manufacturing, supplier, and operational processes.
· Assist with preparation for FDA inspections, CLIA/CAP inspections, state inspections, ISO audits, customer audits, and supplier audits.
· Help organize audit records, evidence, responses, and corrective action follow-up.
· Track audit findings and support timely closure of audit-related actions.
· Maintain inspection-readiness files and support continuous compliance activities.
Supplier Quality Support
· Support supplier qualification, approval, monitoring, and re-evaluation activities.
· Maintain supplier files, supplier questionnaires, quality agreements, certificates, audit reports, and supplier corrective action records.
· Assist with supplier-related investigations, nonconformances, and performance tracking.
· Support incoming material quality documentation as needed.
Validation and Quality Records
· Support organization and maintenance of validation and verification documentation, including method validation/verification, software validation, equipment qualification, process validation, shipping validation, stability studies, and usability-related quality records.
· Ensure protocols, reports, approvals, and supporting records are complete and properly controlled.
· Assist with tracking validation commitments, deliverables, and follow-up actions.
Required Qualifications
· Bachelor’s degree in life sciences, clinical laboratory science, medical technology, engineering, quality, regulatory affairs, or a related discipline.
· Minimum of 3–5 years of experience in quality systems, clinical laboratory quality, IVD, medical device, diagnostics, biotechnology, pharmaceutical, or another regulated environment.
· Working knowledge of quality system processes such as document control, training, CAPA, deviations, complaints, nonconformances, change control, and audits.
· Strong documentation skills and attention to detail.
· Ability to maintain organized, accurate, and inspection-ready records.
· Strong written and verbal communication skills.
· Ability to work cross-functionally with laboratory, quality, regulatory, operations, manufacturing, and product teams.
· Ability to manage multiple priorities and follow through on assigned tasks.
· Proficiency with Microsoft Office, Google Workspace, quality management software, document control systems, or similar tools.
Preferred Qualifications
· Experience supporting FDA-regulated IVD, medical device, or diagnostic products.
· Familiarity with FDA QSR/QMSR, 21 CFR Part 820, ISO 13485, and ISO 14971.
· Experience working in or supporting a CLIA-certified clinical laboratory.
· Familiarity with CLIA, CAP, and state laboratory requirements.
· Experience with laboratory quality records, proficiency testing, competency records, equipment records, QC records, validation/verification documentation, and inspection readiness.
· Experience supporting FDA inspections, CAP/CLIA inspections, ISO audits, customer audits, or internal audits.
· Experience with electronic Quality Management Systems, Laboratory Information Systems, or document management platforms.
· Experience with IVD testing workflows, LDTs, molecular diagnostics, clinical chemistry, infectious disease testing, or specimen collection workflows.
Core Competencies
· Strong attention to detail and documentation discipline.
· Practical understanding of regulated quality systems.
· Ability to organize and maintain complex quality records.
· Strong follow-up and task management skills.
· Clear communication and cross-functional collaboration.
· Inspection-readiness mindset.
· Ability to identify gaps and escalate quality issues appropriately.
· Hands-on, team-oriented approach.
· Commitment to quality, compliance, and continuous improvement.
Physical Demands:
● Ability to sit for extended periods while reviewing documents, analyzing data, preparing reports, and working in electronic systems.
● Ability to stand and walk for extended periods when conducting facility audits, inspections, laboratory walkthroughs, manufacturing/kitting reviews, and cross-functional collaboration activities.
● Ability to lift and carry materials up to 20 pounds, including binders, files, documentation, supplies, and small equipment.
● Visual acuity sufficient to review detailed documents, inspect products and processes, and work effectively with computer systems and electronic documentation.
● Manual dexterity required for computer operation, handling documents, and operating or inspecting quality-related equipment.
● Ability to communicate clearly both verbally and in writing with team members, management, and cross-functional partners.
● Ability to work in laboratory, office, warehouse, and manufacturing/kitting environments and wear required personal protective equipment (PPE) when accessing controlled or laboratory areas.
● Ability to work in a fast-paced environment with multiple priorities, deadlines, and compliance expectations.
Simple HealthKit is an equal opportunity employer committed to providing equal employment opportunities to all qualified individuals regardless of race, color, religion, sex, national origin, age, disability, or any other characteristic protected by applicable federal, state, or local law. We are committed to compliance with the Americans with Disabilities Act (ADA) and the California Fair Employment and Housing Act (FEHA). Simple HealthKit provides reasonable accommodations to qualified individuals with disabilities in accordance with applicable law. The determination of what constitutes a reasonable accommodation will be made on a case-by-case basis through an interactive process between the individual and Simple HealthKit, taking into consideration the essential functions of the position, the nature and cost of the accommodation needed, and whether the accommodation would impose an undue hardship on company operations. Applicants and employees who require an accommodation should contact Human Resources or notify their supervisor or hiring manager to initiate this process.
Pay: $85,000.00 - $110,000.00 per year
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Paid time off
- Vision insurance
Work Location: In person
