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Quality Manager 质量经理 (灭菌) (MJ000012)
30-50万/年
人 · 本科 · 10年及以上工作经验 · 性别不限2024/07/18发布
五险一金补充医疗保险专业培训绩效奖金定期体检周末双休

前滩中心

公司信息
麦朗(上海)医疗器材贸易有限公司

外资(欧美)/150-500人

该公司所有职位
职位描述
Job Responsibilities:
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.


Qualifications:
- Education level: Bachelor degree or above, major with science or engineering background.
- Working experience: Minimum 3 years working experience in related area and have management experience. Experience in medical device is an advantage.
- Able to solve quality issues with systematic problem-solving skills.
- Good communication skills
- Able to work under pressure.
- Proactive, Responsible, Flexible, Positive & Continuous.
- Willing to travel, travel rate is about 30-50%.
- Specific knowledge: Biological and chemical background is preferred.
- Certifications: ISO13485, CFR820 is preferred.
- Language: Fluent at both verbal and written English.

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