QMS Specialist

Job Title QMS Specialist Job Description Job title: QMS Specialist Your role: The QMS Specialist is responsible for supporting the establishment of a compliant and effective Quality Management System (QMS) for the activities in scope. The role participates in developing and revising QMS process documents, such as SOPs and quality manuals, ensuring their accuracy and currency. The role works under general supervision, and collaborates with cross-functional teams to resolve quality issues through root cause analysis and corrective actions. The role collects and reports data on QMS performance metrics and tracks non conformance reports, contributing to continuous improvement activities. You're the right fit if: (4 x bullets max) 1. Experience: 6–10 years; mid-level professionals. 2. Skills: • Strong experience in document control and QMS documentation, including use of PLM and electronic document management systems such as Windchill; managing controlled documents, revisions, approvals, and change workflows; and maintaining device master record (DMR) or equivalent product documentation files. • Good understanding of QMS standards and regulations, including ISO 13485, FDA QMSR, and EU MDR; experience with QMS processes like training, and participation in internal and external audit. • Participates in the effective deployment and continuous improvement of QMS processes in the assigned area/ areas such as document control, training, and audits, by providing technical expertise and ensuring compliance with regulatory standards. • Collects, compiles, and reports data on QMS performance metrics, such as non-conformances, critical findings, and training completion rates, to support management in decision-making. • Contributes to continuous improvement initiatives by identifying opportunities for enhancing efficiency and compliance within existing QMS processes and providing support in implementing improvements. • Participates in the planning and organization of internal audits by preparing necessary documentation, assisting audit teams during audits, and ensuring follow-up actions are completed. • Ensures the proper maintenance, organization, and archiving of quality records in accordance with QMS procedures, regulatory requirements, and company policies to maintain audit readiness. • Collaborates with cross-functional teams and stakeholders to ensure effective communication and understanding of QMS processes, and provide basic guidance on compliance-related inquiries. • Participates in problem-solving sessions by providing data and insights related to quality processes, supporting the identication of root causes, and recommending potential corrective actions. • Works under general supervision and established processes, utilizing independent judgment to navigate and adhere to operational policies, ensuring compliance and optimal performance. • Engages in risk management activities, identifying potential risks to regulatory compliance, quality and QMS integrity, and proposing mitigation strategies to minimize impact. • Participates 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. • Develops professional expertise and applies comprehensive knowledge of company products and services to effectively address challenges and opportunities 3. Education: Bachelor of Engineering and/or MSc. (Science, Biomedical, Biotech, etc) 4. Anything else: • Regulatory Requirements • Quality Management Systems (QMS) • Troubleshooting • KPI Monitoring and Reporting • Data Analysis & Interpretation • Process Improvements • Agile Methodology • User Training & Support • Training Content Development • Business Acum