Quality Manager, Sterilization

JOB SUMMARY: Provide a brief summary of the overall purpose of the role within the organization.

The QA Manager- Sterilization will focus on the suppliers’ management process in Asia including but not limited to China. This position will work closely with cross-function teams to ensure that the suppliers and related purchased products meet Quality and Sterilization requirements and support Medline Global Sourcing Organization to build a robust and sustainable supply chain.

CORE JOB RESPONSIBILITIES: List the primary/essential job duties and responsibilities & the objectives of the role.

1. Manage new suppliers and products development process that related to sterility assurance in Asia by doing below:

• Supplier audit against related standards (CFR820, ISO13485, ISO11135, ISO11137, etc.)

• ETO sterilization validation

• Steam sterilization validation

• Irradiation validation

• Packaging validation

2. Manage existing suppliers and products sterility assurance related activities in Asia by doing below:

• Sterilization revalidation

• Routine sterilization audit

• CAPA, SCAR

3. Collaborate and interact with cross-functional teams within Medline. Provide technical supports, suggestions, training as needed. Align with key stakeholders to enable goal attainment.

4. Seek opportunities for continuous improvement of processes and techniques. Able to get resources to implement the plan. Update procedures as needed to maintain compliance and improvement.

5. Build the competent team by making and implementing clear team development plans with comprehensively considering Medline GSO needs and resources.

• Develop and coach the team though on-boarding, training, performance management and development opportunities.

• Provide appropriate feedback and direction in time.

• Seek team members’ insights and work collaboratively towards goals with individual perspectives integrated.

• Support initiatives to build and maintain team engagement and positive employee morale.

6. Other work assigned by Leader or manager.

BASIC Technical Skills: List essential abilities in practical & technical knowledge which are required to perform the job.

• Plan and align work: plan and prioritize work;

• Direct work: to provide direction, delegate, remove obstacle to get team work done

• Optimize work process;

• Have high sense of urgency and build good relationship with others;

• Good at presentation in English.

Qualification: please state the minimum & necessary qualification required to successfully perform the job.

• Education level: Bachelor degree or above, from engineering/ or R&D or related.

• Working experience: At least 8 years working experiences in quality and engineering areas, 3 years in people management role; experience in medical device and supplier development, and project management;

• Specific knowledge and requirements: Be familiar with ISO13485 requirements and quality management tools, be able to handle multiple tasks/projects in the same time, be team player, and be able to travel according to business needs (>50%).

• Language: good at English especially verbal English

Leadership Competency: Applicable to manager level position; list the required to successfully perform the job. And the listed competency should be reflected the job responsibilities.

• Manage Complexity;

• Plans & Aligns, Directs Work;

• Optimizes Work Process;

• Attract and Develop Talents;

• Demonstrate Self-awareness.

Additional: Please state the preferred but not essential requirements

• Be familiar with EO sterilization process and requirements;

• Be able to communicate in Mandarin;

• Have continuous improvement background.