Quality Management System/CAPA Specialist

You're the right fit if

• You have a minimum of 3+ years’ experience in CAPA management, Quality Management Systems, Quality Audits in highly regulated environments/industries such as Medical Device, Pharma or Automotive. FDA regulated Medical Device preferred.
• You have proven knowledge of global medical device regulations, requirements, and standards, such as QMSR, ISO 13485, ISO 9001, and EU MDR-preferred.
• You have detailed experience/knowledge of the CAPA process, including problem identification, root cause analysis, corrective action planning, effectiveness verification, technical writing and CAPA timeliness management. You train and support CAPA teams accordingly.
• You’re experienced in Data analysis, detailed reporting of QMS metrics/KPI’s, highlighting trends, deviations, areas for improvement, and presenting findings to senior management.
• You’re able to build/cultivate relationships with supervisors, functional peer groups, and internal/external stakeholders.
• You have a minimum of a Bachelor’s Degree (Required), in Quality, Engineering or similar disciplines. ASQ-CQE certification-desired.
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.

Your role

1. 1Takes ownership of processes in the assigned area/ areas (CAPA, Audit Readiness and related Document Control, Training) to ensure that QMS is efficient and meets the regulatory requirements.
2. 2Analyzes QMS metrics and performance indicators, preparing detailed reports that highlight trends, deviations, and areas for improvement, and presenting findings to senior management.
3. 3Works under limited supervision and broad guidelines, regularly applying independent judgment on matters of significance to drive project success and compliance.
4. 4Contributes to the development, implementation, and revision of QMS processes, including standard operating procedures (SOPs), work instructions, and quality manuals, ensuring their accuracy, clarity, and compliance with relevant standards.
5. 5Conducts risk assessments activities, identifying potential risks to regulatory compliance, quality and QMS integrity, and developing robust mitigation strategies to minimize their impact.
6. 6Participates in continuous improvement initiatives within the QMS, proposing and implementing enhancements to processes, tools, and systems to drive overall quality performance and operational excellence.
7. 7Applies specialized knowledge in breadth and/or depth to a variety of issues and projects within the team, ensuring effective solutions and innovative approaches to complex challenges.
8. 8Participates in training sessions to stay updated on quality standards and QMS procedures, actively engaging in learning opportunities to enhance understanding of industry regulations and best practices.
9. 9Cultivates effective relationships with internal and external partners, providing influence over projects and peer groups by demonstrating a comprehensive understanding of the area of specialization.
10. 10Leads cross-functional problem-solving sessions to address significant QMS issues, utilizing structured methodologies like root cause analysis and driving the implementation of solutions.
11. 11Prepares for and participates in external regulatory audits and inspections by ensuring readiness of documentation, processes, and records, and provide responses to audit findings in collaboration with stakeholders.