The posting
Key Purpose
The QM Senior Specialist will be responsible for ensuring the effective implementation and monitoring of following QMS processes, namely Document Control, Change Control, Complaint Management and FSCA/FCA for Non-SCORP products at RHQ (SAP). This role will be responsible for driving any improvement initiatives driven by SAP to all Affiliates in the region to strengthen the quality level and mitigate and minimize any risks that may occur. Additionally, this role will support the Quality Manager in Quality Operations and oversee all Process FMEAs to be complying to ISO14971.
Key Responsibilities
ISO 13485 / ISO 9001: Quality Management System
- Assists the QM Manager in maintaining the Quality Management System (QMS) to ensure continued compliance with the latest requirements of ISO 13485, supporting the organisation's commitment to quality excellence.
- Unless appointed as Lead Auditor, this role shall support the QM Manager in planning and conducting Internal Audits for SAP, as well as external audits to Affiliates and Business Partners (where required), in accordance with ISO 13485, ISO 9001, ISO14001 and ISO27001 standards.
- Supports the QM Manager in the preparation of Management Review meeting material, ensuring all required inputs, data, and documentation are accurate, completely compiled and submitted to Quality Management Representative (QMR) for final consolidation 2 weeks prior to actual MR meeting.
- Supports QM Manager in overseeing the internal Corrective and Preventive Action (CAPA) process for both factory and office functions, ensuring timely investigation, implementation, and closure of corrective actions. Performs data trending monthly for reporting at CRB meeting and inputs to Management Review.
Document Control
- Serves as the primary Document Controller, assuming overall responsibility for the end-to-end management of the Document Control system, ensuring all quality management (QM) related documents are accurate, current, and compliant with regulatory and organisational requirements.
- Oversees the review, approval, issuance, and archival of controlled documents received from various departments, maintaining strict version control and document integrity throughout the entire document lifecycle.
- Takes the initiative to improve and strengthen the Document Control system by improving consistency, clarity, and efficiency across all documentation processes.
- Liaises proactively with cross-functional departments to facilitate timely document submissions, reviews, and updates, ensuring seamless coordination and adherence to established Document Control procedures.
- Maintains and manages the Document Control register and filing system, ensuring full traceability, easy retrieval, and proper retention of all controlled documents in accordance with applicable standards.
- Drives and lead any improvement projects in document management by identifying process gaps, recommending enhancements, and implementing corrective measures to uphold the integrity and effectiveness of the Document Control system.
Change Control
- Serves as Change Control Manager, overseeing and managing Change Control requests from manufacturing sites (SIP and SAP) by critically evaluating change submissions and collaborating with the S-Corp Change Board to facilitate informed decision-making and timely approvals.
- Leads and coordinates the Change Control impact assessment process on behalf of S-Corp, engaging cross-functional stakeholders to gather comprehensive assessment inputs, consolidating findings, and ensuring accurate and timely communication back to the manufacturer.
- Maintains diligent oversight of all Change Control activities by proactively monitoring, tracking, and updating the status of change requests to ensure compliance, transparency, and on-time closure.
- Actively represents the organisation as a key participant in Change Control meetings at the factory level, contributing technical insights and driving alignment between the manufacturing site and S-Corp on change-related matters.
- Notify QMR immediately for any changes which impact SAP ISO certification and warrant a Change Notification to external Certification Body with document supplement.
Quality Complaint Management (Reagent)
- Supports the QM Manager by proactively monitoring and managing customer complaints received from customers and business partners through the GES system, ensuring all complaints are identified, assessed, and acted upon in a timely manner. Understand and set clear escalation criteria for Level 1 to 3 at SAP, understand such escalation at Affiliates.
- Exercises sound judgement in evaluating complaint submissions to determine quality-related issues, taking ownership of gathering comprehensive information and physical evidence required to facilitate thorough investigations by manufacturers, and ensuring prompt escalation into TrackWise, the complaint tracking system.
- Serves as the primary liaison between manufacturers and complaint senders, actively managing communication and driving the resolution process to ensure complaints are addressed effectively and closed in a structured and traceable manner.
- Delivers clear, accurate, and timely communication of investigation conclusions to customers and business partners, demonstrating strong commitment to customer satisfaction and ensuring all cases are resolved to the satisfaction of all stakeholders before formal closure.
- Performs data trending monthly for reporting at CRB meeting and inputs to Management Review.
Operational Quality Support
- Oversees Process FMEAs in SAP.
- Provides dedicated quality support to the Production and Quality Control (QC) teams by serving as a knowledgeable resource and trusted advisor on all quality-related matters, ensuring that quality standards are consistently upheld across all operational activities.
- Oversee the management of Non-Conformance Events (NCE) and non-conforming products, ensuring all instances are promptly identified, documented, and escalated in accordance with established quality procedures and regulatory requirements.
- Leads and facilitates root cause analysis (RCA) activities for quality-related issues arising from production and QC operations, applying structured problem-solving methodologies to identify underlying causes and drive the implementation of effective and sustainable corrective actions.
- Provides hands-on guidance and consulting support to Production and QC teams in addressing and resolving quality issues, offering practical recommendations and technical expertise to prevent recurrence and minimize operational impact.
- Collaborates closely with cross-functional teams to investigate non-conforming products and NCEs, ensuring thorough documentation of findings, timely resolution, and proper disposition of affected products in compliance with quality and regulatory standards.
Requirements
- Relevant Diploma / Degree in relevant scientific or engineering discipline.
- Minimum 5 years of experience in a Quality Assurance role within the Healthcare industry.
- Certified Lead Auditor for ISO 13485 and/or ISO 9001.
- Knowledge and experience in ISO 14001 internal audits and Workplace Safety and Health requirements.
- ISO 13485 / ISO 9001 Quality Management Systems (QMS).
- ISO 14001 Environmental Management System (EMS).
- ISO 27001 Information Security Management System (ISMS).
- Workplace Safety and Health Act.
- Microsoft Office applications.
- Experience with Complaint Handling systems (e.g. TrackWise) is an advantage.
- Knowledge of Computer System Validation (CSV) and understanding of 21 CFR Part 11, Part 210 and Part 820 will be beneficial.
- Responsible and self-motivated.
- Strong team player.
- Keen to learn and continuously improve.
- Good communication and interpersonal skills.
- Experience in the In-vitro Diagnostics (IVD) industry is preferred but not essential.
- Approximately 10% travel.
