Quality System Specialist

Description

• Provides oversight for the development, implementation, and maintenance of quality programs, systems, processes, and procedures that ensure compliance with company policies and that the performance and quality of products and services conform to established internal and external standards, including ISO 13485 and applicable EU, FDA, APAC regulatory requirements.
• Provides expertise and guidance to co-workers in interpreting quality and regulatory requirements, including MDR (where applicable), and internal quality system procedures.
• Works directly with cross-functional teams (e.g., Sales & Marketing, Supply Chain/Operations, Regulatory Affairs, and Service) to provide ongoing process analysis and quality oversight to ensure compliance, identify risks, and drive continuous improvement.
• Supports internal and external audit and inspection preparation, participates in audits, and ensures timely resolution and documentation of audit and inspection findings.
• Prepares, reviews, and maintains quality documentation, including management review inputs, risk assessments, metrics, and key performance indicators (KPIs).
• Leads or supports compliance-related activities such as audit readiness, nonconformance management, root cause analysis, Corrective and Preventive Actions (CAPA), and continuous improvement initiatives.
• May act as lead or contributor for other quality functions including document control, software validation, supplier quality, and design control activities.
• Ensures the quality management system (QMS) documentation and processes are maintained, updated, and improved to reflect current regulatory and business requirements.
• Participates in change control, product release, and post-market surveillance activities to ensure compliance and effective risk management.
• Collaborates globally to align on quality system processes, facilitate best practice sharing, and support harmonization of quality standards across regions.
• Supports training and awareness initiatives to ensure quality culture and compliance throughout the organization.

Qualifications

• Bachelors degree required with minimum of 3 years of relevant experience
• Medical device industry with relevant regulatory and standards knowledge
• Working knowledge of ISO 13485, ISO 14971, and relevant international medical device regulations.
• Audit Backroom and/or Front Room roles
• Experience in CAPA, internal audits, and post market quality processes
• Problem solving or process improvement methodology (e.g. Six Sigma, Lean, 5 Why, Kaizen)