Role Description

The SSMR-MR Quality Director is assigned as Quality Management Representative for SSMR-MR.

The mission for the SSMR-MR Quality Director is to operatively establish, maintain and optimize SSMR-MR Quality Management System (QMS) including required certifications according to the business requirements and the Healthcare directives.

He/she consults the SSMR-MR management (GM, Heads of R&D, Manufacturing etc.) regarding current and future quality/regulatory requirements and risks.

He/she drives together with the SSMR-MR management continuous improvement in order to reach world-class quality within the SSMR-MR.

He/she directs professionally all quality staff of the SSMR-MR.

In this role, he/she has the authority and is obliged to stop any processes and projects in cases where the corresponding quality and regulatory requirements are not fulfilled in the SSMR-MR.

He/she reports directly to the SSMR-MR GM and to the Head of HQMR QT (shared management responsibility).

Key Responsibilities

1. Quality Management System: Effectively establish, maintain and optimize a consistent QMS in the SSMR-MR, including required certifications based on external quality/ relevant regulatory requirements (e.g, US CFR820, ISO13485, ISO9001, China GMP) and in alignment with the Siemens Healthcare relevant regulations. Ensure that processes needed for the QMS are documented.

2. Quality Reporting: Reporting on the performance and effectiveness of the QMS as well as any need for improvement to SSMR-MR top management. Prepare and conduct management reviews.

3. Communication regarding Quality: Implement communication measures to ensure a SSMR-MR wide awareness of applicable regulatory requirements and understanding of the SSMR-MR QMS requirments. Ensure external communication towards economic operators, customers, suppliers (aligned with Procurement) and to external authorities/Notify Body on Quality related topics. Represent GM regarding QM topics.

4. Ensure (a) identification of critical business issues, (b) prioritization of improvement projects / actions, (c) realistic budget and resource planning, (d) selection of financial and non-financial KPIs, (e) benchmarked target values. Drive non-conformance costs (NCC) as one quality focus topic.

5. Customer Integration: Facilitate methodologies to analyse customer complaints/feedbacks and to identify relevant KPIs for the quality reporting. Ensure escalation process with fast complaint Handling and trending analysis. Ensure Reporting (Reportable Event/Field update) according to relevant regulations.

6. Quality in Processes and Projects: Ensure and control implementation of quality tools in processes / projects, e.g. quality gates. If necessary, use authority to refuse development, production, shipping and acceptance release.

7. Quality-based Supplier Management: Ensure supplier quality management with best management methods and processes in alignment with Healthcare specific requirements, to secure the delivered quality and reduce NCC caused by suppliers. This comprises supplier related processes like selection, qualification, development, integration, monitoring and auditing. Advise on the agreement of quality targets for suppliers, on quality assurance agreements and on continuous improvement activities with suppliers. Incorporate the results into SSMR-MR quality report.

8. Qualification for Quality: Coordinate with HR to implement a SSMR-MR competency management and training system to ensure employee role-based required training is identified. Design, develop and deliver SSMR-MR quality and regulatory related training.

9. Responsibilities according to China GMP requirement (see attachment).

10. Responsibilities according to EU 2017/745 MDR article 15 requirement (details see PRRC appointment letter). PRRC shall suffer no disadvantage within the manufacturer’s organization in relation to the proper fulfilment of his or her duties.

11. Authorities: (a) Provide leadership and escalation for Quality Coaches in the SSMR-MR in matters of quality non-conformity or critical quality deviations, e.g. product safety. (b) Participate in the assignment of new Quality staff. (c) Intervene, overrule and escalate in the case of non-conformity of regulations and quality relevant procedures. (d) Release and stop of deliveries and services in accordance with the definitions in the Quality Policy. (e) Unrestricted access to all quality relevant data e.g. customer contracts, risk assessments, financial data, project plans, target settings for decision making.

Requirements

· More than 8 years of related experience with proven track record, e.g, Quality Management, Regulatory Affair, Medical Device Manufacturer.

· Quality management methods/statistical methods

· Quality assurance know -how, product safety and risk management

· Procedure & standards understanding

· Medical device knowhow

· Master the regulations of medical device, supervise related policy to keep it align with national policy

· Bachelor degree on Engineering, or other relevant qualification and above