Quality Assurance Specialist II

Quality Assurance Specialist II

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.

Responsibilities include:

• 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.
• 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.
• 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.
• Research, organize, analyze, and present historical quality and manufacturing data in support of FDA submissions and responses to agency questions, including PMA-related activities.
• Ensure relevant quality events and post-production information are evaluated for potential linkage to product risk management activities.
• Serve as a subject matter expert and escalation resource for document control and training processes administered day-to-day by the QA Associate.
• Schedule and coordinate the internal audit program as assigned and support remediation and closure of audit findings.
• 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.

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.