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水平: Associate
工作类型: Part-time
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工作内容
JOB TITLE: QUALITY OFFICERJob Summary
Will serve as main point of contact for quality matters at the site.
Will work closely with all other site departments to ensure an effective implementation of the global quality system requirements and to ensure the quality of products manufactured and serviced at the site.
Essential Duties And Responsibilities
- Serve as site expert for execution of quality related global processes (NC, CAPA, Complaint, Doc&Change control).
- Acts as the policy / procedure owner for area(s) of responsibility, ensuring they are compliant and effective.
- Perform quality inspection/tests and review production records issued by production.
- Release to the market all finished products manufactured by the Leuven site and the incoming goods for production.
- Follow-up on non-conformities detected during incoming inspection, production and servicing.
- Drive the site complaint handling process related to distributed products in the region.
- Monitor the health of the site QMS within area of responsibility and provides metrics to management as required.
- Serves as Subject Matter Expert for QMS area(s) of responsibility during audits and inspections.
- Contribute to site, regional or corporate quality improvement projects as required and support the implementation of resulting action plan.
Education
Bachelor’s degree (technical orientation) or, equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.
Experience
- Minimum 2 years of experience in an administrative role.
- In line with Terumo’s Core Values:
- Respect - Appreciative of others
- Integrity - Guided by our mission
- Care - Empathetic to patients
- Quality - Committed to excellence
- Creativity – Striving for innovation
- Demonstrated ability to communicate effectively both verbally and in writing in English and Dutch.
- Strong interactive skills in cross functional participation and influence, mentoring and acceptance of guidance, team behavior.
- Capability to interact with diplomacy and tact while maintaining appropriate assertiveness.
- Self-directing and ability to work with minimal supervision.
- Ability to deal effectively with complexity.
- Strong analytical abilities.
- Must be detail oriented, accurate, well organized.
- Product technical knowledge, GMP and Quality Processes.
- Knowledge of Quality Systems requirements
- Knowledge and use of relevant PC software applications and skills to use them effectively.
An equivalent competency level acquired through a variation of these qualifications may be considered.
Physical Requirements
Typical Office Environment requirements include: reading, speaking, hearing, close vision, walking, bending, sitting, and occasional lifting up to 20 pounds.
The physical demands described here are representative of those that must be met by an associate to successfully perform the essential duties of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.
Additional Information
- This position is based in Leuven – Belgium.
- Reporting to the QA Manager.
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最后期限: 22-12-2025
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