Senior Quality Systems Specialist

What You Will Do

• Own and oversee the Nonconformance (NC) and Corrective and Preventive Action (CAPA) processes to ensure compliance, effectiveness, and efficiency in addressing quality issues.
• Review and approve NCs and CAPAs for completeness, accuracy, effectiveness, and timeliness.
• Partner with cross-functional teams to facilitate investigations, root cause analysis, and corrective action implementation.
• Serve as the site subject matter expert and super user for the eCAPA system, ensuring records are maintained with appropriate supporting evidence.
• Coach and mentor teams on problem-solving methodologies, including 5 Whys, Fishbone Diagrams, Process Mapping, Human Error Reduction, and 4-D methodologies.
• Lead accountability meetings, CAPA review boards, and root cause analysis workshops to drive quality improvements.
• Monitor and report NC/CAPA key performance indicators (KPIs), providing updates for quality and business review forums.
• Develop, maintain, and deliver training programs related to CAPA processes and quality systems.
• Identify and implement continuous improvement initiatives to optimize quality systems and business processes.
• Participate in cross-site and corporate quality system improvement projects.
• Support internal, corporate, customer, and third-party audits, including preparation, participation, and follow-up activities.

What You Need

• Bachelor's degree in Science, Engineering, or a related discipline.
• Minimum 3+ years of experience in a manufacturing environment or equivalent.
• Strong communication, project management, and influencing skills.
• Demonstrated ability to manage multiple priorities in a fast-paced, matrixed environment.
• Strong analytical, critical thinking, and problem-solving capabilities.
• Ability to work independently and drive issues to resolution.
• Proficiency with Microsoft Office applications, including Word, Excel, and PowerPoint.

Preferred

• 2+ years of experience in CAPA, Quality Systems, Quality Engineering, or a related field.
• Experience interacting with regulatory agencies such as FDA, TUV, and other international regulatory bodies.
• Knowledge of U.S., European, and international medical device regulations and standards.
• Strong understanding of quality system processes, including audits, management review, and quality planning.
• Experience working in compliance-risk environments.
• Demonstrated success leading projects and driving results across cross-functional teams.
• Excellent written, verbal, and negotiation skills.
• Ability to facilitate teams through complex investigations and root cause analyses.
• Experience supporting multi-site or global quality initiatives.
• Willingness to travel as needed.