Quality Assurance Specialist II

Quality Assurance Specialist

Job Purpose

The Quality Assurance Specialist is an experienced individual contributor who independently owns and operates defined Quality Management System processes and exercises judgment on routine and moderately complex quality and compliance matters. The position serves as a subject matter expert for assigned quality systems, drives timely resolution of quality events, supports product disposition and regulatory activities, analyzes quality system performance, and leads defined process improvements with minimal oversight.

The QA Specialist works collaboratively with the QA Associate and Sr. Quality Systems Engineer. The QA Associate provides day-to-day administration for document control, training, and asset management, while the QA Specialist provides process expertise, escalation support, backup coverage, and quality-system oversight as assigned. The Sr. Quality Systems Engineer partners with the QA Specialist on complex investigations, risk management, system design, validation/CSA, statistical analysis, and cross-functional quality-system improvements. The QA Specialist does not have direct supervisory responsibility for the QA Associate unless specifically assigned.

Batch Release

• Own and execute assigned batch release activities, ensuring release decisions and documentation are completed in accordance with approved procedures, product requirements, and applicable regulatory requirements.
• Evaluate routine release discrepancies and coordinate resolution or escalation of issues requiring additional technical, regulatory, or management review.
• Train and support qualified personnel in batch release procedures and Electronic Batch Record (EBR) capabilities as new systems are introduced.
• Partner with Operations and the Sr. Quality Systems Engineer to model, implement, and improve EBR processes and associated controls.

Quality Events – NCMR, Deviation & CAPA

• Serve as process owner or primary QA subject matter expert for assigned NCMR, deviation, and CAPA processes, ensuring records are appropriately initiated, investigated, reviewed, approved, and closed within established timelines.
• Triage quality issues raised across the organization and determine the appropriate quality-system pathway, escalation, and required follow-up.
• Lead or support investigations and structured root cause analysis for routine and moderately complex quality events; partner with the Sr. Quality Systems Engineer and technical functions on complex, systemic, or cross-functional investigations.
• Assess quality events for potential impact to released product, product disposition, validation status, regulatory commitments, and risk management activities, escalating as appropriate.
• Drive CAPA timelines, evaluate adequacy of corrections/corrective actions and effectiveness activities, and train employees on successful execution of quality event processes.
• Monitor quality event trends and recommend systemic actions or process improvements when adverse or recurring patterns are identified.

Asset Management – Process Oversight

• Serve as QA process owner/subject matter expert for the calibration and preventive maintenance quality system, with day-to-day scheduling, record maintenance, and tracking administered by the QA Associate.
• Review and assess overdue, out-of-tolerance, incomplete, or otherwise non-conforming asset situations and determine or coordinate required quality-system actions.
• Provide training, procedural guidance, and backup coverage for asset management activities and drive improvements to the calibration/preventive maintenance process.
• Partner with the Sr. Quality Systems Engineer and equipment owners on qualification, validation, technical assessments, or systemic equipment-control issues as appropriate.

Regulatory Submission & Inspection Support

• Research, organize, analyze, and present historical quality and manufacturing data in support of FDA submissions and responses to agency questions, including PMA-related activities.
• Support preparation for FDA inspections, Notified Body audits, ISO 13485 audits, customer audits, supplier audits, and internal audits.
• Lead or support audit backroom activities, including request management, record retrieval coordination, response tracking, and communication with subject matter experts.
• Serve as a Quality Assurance subject matter expert during audits and inspections for assigned quality-system processes.

Risk Management, Standards & Quality Engineering Partnership

• Ensure relevant quality events and post-production information are evaluated for potential linkage to product risk management activities.
• Partner with the Sr. Quality Systems Engineer and technical functions on updates to Risk Management Files, risk probabilities, and other ongoing risk-management activities.
• Apply structured Root Cause Analysis methodologies and appropriate data analysis to quality investigations; engage the Sr. Quality Systems Engineer for complex statistical, technical, or systemic analyses.
• Support gap analyses of new and revised standards and regulations applicable to company products and quality systems in partnership with the Sr. Quality Systems Engineer and Regulatory Affairs.
• Participate in implementation of resulting quality-system changes and verify completion of assigned actions.

Document Control, Training & eQMS

• Serve as a subject matter expert and escalation resource for document control and training processes administered day-to-day by the QA Associate.
• Provide backup coverage for document control, training administration, and related quality records when needed and appropriately trained.
• Review or approve controlled documents within assigned authority and provide guidance to authors and process owners on Quality System requirements.
• Conduct or coordinate GMP/QMS and process-specific training as assigned.
• Partner with the QA Associate and Sr. Quality Systems Engineer on eQMS implementation, migration, workflow design, testing, validation/CSA activities, and ongoing process improvement.
• Define or contribute Quality Assurance requirements for eQMS workflows involving quality events, document control, training, batch release, and other assigned processes.
• Update SOPs and Work Instructions to align with approved quality-system and eQMS processes.

Audits, Metrics & Quality System Improvement

• Schedule and coordinate the internal audit program as assigned and support remediation and closure of audit findings.
• Compile, analyze, and present monthly quality metrics and identify trends requiring management attention or further investigation.
• Compile and analyze information for Management Review and support preparation of Quality Management System performance summaries.
• Lead defined quality-system improvement projects and track action items, timelines, risks, and deliverables.
• Provide quality guidance to Operations, Product Development, and other functions on assigned Quality System processes and escalate decisions outside assigned authority.

Cross-Functional Coordination & Backup

• Coordinate closely with the QA Associate to maintain continuity of document control, training, asset management, and other assigned Quality Assurance processes; provide cross-training and backup coverage without direct supervisory responsibility.
• Interface routinely with the Sr. Quality Systems Engineer on investigations, risk management, validation/CSA, eQMS implementation, standards, data analysis, and systemic quality improvements.
• Train and guide personnel on assigned Quality System processes and may provide functional direction for specific activities or projects.
• Perform other duties and quality projects as assigned.

Skills / Qualifications

• Bachelor's degree in a scientific, engineering, technical, or related discipline and typically 3–5 years of Quality Assurance/Regulatory Affairs experience in a regulated industry; medical device highly preferred. Relevant experience may be accepted in lieu of degree.
• Working knowledge of ISO 13485 and 21 CFR Part 820 (Quality Management System Regulation/QMSR); exposure to FDA submission processes, including PMA activities, preferred.
• Familiarity with ISO 14971 risk management principles, structured Root Cause Analysis methodologies, and quality-system data analysis.
• Demonstrated ability to independently manage quality-system processes such as CAPA, NCMR/deviation, calibration/preventive maintenance oversight, document/training systems, or batch release with minimal supervision.
• Experience supporting regulatory, Notified Body, customer, or internal audits and ability to serve as a subject matter expert for assigned processes.
• Strong analytical, problem-solving, written, and verbal communication skills, including the ability to train and guide personnel and communicate quality issues to cross-functional stakeholders.
• Proficiency with Microsoft Word, Excel, PowerPoint, and electronic Quality Management Systems (eQMS).
• Ability to balance independent process ownership with effective collaboration, escalation, and cross-functional decision-making.
• Positive, collaborative, and accountable working style with willingness to take on additional tasks and projects as assigned.