Quality Assurance Specialist

The Quality Assurance Specialist provides advanced quality assurance support across manufacturing and quality to ensure products, processes, and documentation meet established internal, customer, and regulatory requirements. This role independently reviews quality records and product release documentation, leads or supports investigations and corrective actions, analyzes quality trends and risks, and supports internal, supplier, and external audits. This position collaborates with Manufacturing, Quality, and other cross-functional departments. The Quality Assurance Specialist applies quality system knowledge and risk-based decision making to resolve complex quality issues, improve processes, and maintain compliance with applicable Quality Management System requirements, including ISO 9001 and ISO 13485.

To perform this job successfully, an individual must be able to capably perform each of the following essential duties:

• Review and approve quality and product-release records, including batch records, QC results, environmental monitoring records, and related documentation, to verify compliance with internal specifications, customer requirements, procedures, and established standards 

• Independently investigate quality issues, nonconformances, deviations, and customer complaints; partner with cross-functional teams to determine root cause and identify appropriate actions to address product and process concerns 

• Initiate and support Corrective and Preventive Actions (CAPAs), including documenting investigations, determining appropriate corrections and corrective actions, monitoring implementation, and supporting timely and effective resolution of quality issues 

• Review quality data and metrics to identify trends, recurring issues, and emerging risks, and recommend actions to improve product quality, process performance, and overall Quality Management System effectiveness 

• Investigate quality issues and trends from customer complaints, NCMRs, CAPAs, and other quality records 

• Review risk management documentation and actions for completeness, feasibility and adequacy. Track mitigation efforts to reduce medium and high risks to acceptable levels 

• Identify improvements to reduce scrap, rework, complaints, and other sources of Cost of Poor Quality (COPQ) in line with quality and cost reduction initiatives 

• Review and approve Document Change Requests (DCRs) related to materials, production processes, and test methods 

• Initiate SOP changes to streamline, standardize, and improve quality system processes 

• Support new product development and design-control activities by participating in cross-functional reviews and completing assigned Quality Assurance deliverables to ensure quality requirements are incorporated throughout product development 

• Perform internal and supplier audits, issue audit reports, and follow up to close out actions which address the findings 

• Provide training and support for quality concepts and tools 

• Support New Product Development to include attending design control meetings and completed Quality Assurance Deliverables  

• Support and Host External Audits  

• Perform other duties as required, or assigned by management, to meet business needs