- Bachelor's Degree
- Minimum of 5 years of experience in medical device or pharma regulated environment in the areas of Quality, Manufacturing, or related field.
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Quality Specialist - Shanghai, 中国 - Advanced Sterilization Products
描述
Responsibilities
·Implements and supports ASP Quality Management System and its integrated programs within the respective region, such as quality systems training, internal audits, nonconformances, corrective and preventive action, records management, field actions, supplier quality management, procurement, servicing, distribution, and post market surveillance.
·Assures compliance with applicable regulations such as, but not limited to, FDA 21 CFR 820, ISO 13485, EU MD Directive/Regulations, China GSP & GMP.
·Maintains, sustains and continuously improves the Quality Management System and monitors the performance and health of the Quality Management System through metrics and analytics.
·Establish local and regional relationships with regulatory affairs, commercial, and logistics team.
·Maintains quality oversight of local distribution and warehouse management process (assessment, qualification, monitoring).
·Maintains quality oversight of any local required establishment licences, or QMS certifications.
·Supports local supplier/vendor selection, qualification, and audits.
·Maintains process for kitting/repack/relabeling activities (if any)
·Ensures timely investigation of nonconformances.
·Establish corrective and preventive actions to mitigate potential or actual noncompliance risks.
·Maintains quality oversight of field service processes/procedures.
·Assesses product quality issues and escalates to upper management through established processes.
·Ensures timely post-market surveillance & vigilance (Field Actions and Product Complaints) management
·Ensures timely and consistent escalation of events.
·Support market quality compliance activities as required by the direct manager and in collaboration with associates.
·Collaborate cross-functionally to support projects assigned by the direct manager.
·Responsible for communicating business related issues or opportunities to next management level.
·Performs other duties assigned as needed.
Qualifications
§Demonstrated knowledge of regulatory standards and regulations, such as, but not limited to, FDA 21 CFR 820, EU MD Regulations, China GSP & GMP, ISO 13485, ISO 9001, ISO 14971.
§Ability to work and communicate in a cross-cultural environment
§Excellent communication skills both written and verbal
§Highly developed influence, interpersonal, communication and conflict resolution skills
§Ability to interact with all levels and disciplines within the organization
§High sense of urgency, adaptable to meet rapidly changing priorities
§Proven analytical/quantitative skills
