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Sr.Quality System Engineer ????????? Hangzhou Smiths Medical Hangzhou

Sr.Quality System Engineer ????????? Hangzhou

Smiths Medical
Hangzhou ZHEJIANG
2020-11-17 18:00:31
Sr.Quality System Engineer ????????? Hangzhou
Sr.Quality System Engineer ?????????

Location

Asia Pacific, China, Hangzhou

Job Reference

MEDAPAC00257

Job Function

Reg Affairs & Quality Assurance

About us

Smiths is always looking for curious minds. For new colleagues who want responsibility and relish a challenge. Those who would like to use their talents to help make the world safer, healthier, more efficient and more connected.

We're proud that we've been helping propel the human world forwards during our 160 year history of innovation by looking at things differently By adapting and never standing still. And by always thinking big.

Today we're an aligned global business of five divisions and around 2.000 colleagues that touches the lives of millions every year across five vibrant global markets.

Responsibilities/Duties ??/?? 1:

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Training Coordinator, Role assigned to a person whose responsibilities include maintenance of the master training matrix and ensuring... all required Quality training is completed and documented accurately at the site. Be responsible for:
• ??????????????????5????????????????
• Providing all new employee's with his/her personal training folder before they receive any training or within 5 days of his/her start date.
• ??????????????????????????????
• Updating and maintaining the master training matrix in partnership with management.
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• Supporting managers/supervisors with implementation/execution of the training per the MTM.
• ????????????????????????????
• Tracking and reporting metrics on completion of Quality System training per the MTM requirements.
• ??????????????????????????????????/???????????
• Notifying manager/supervisor or designee of incomplete training per the assigned work of the employees within his/her area of responsibility.
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• Storing and retrieving training records for training required in accordance with the Quality System when asked by management, HR, an internal auditor, or an external inspector.
• ??????Smiths????Smiths???????????????????????
• Storing completed training records when an employee transfers to another Smiths Medical or Smiths Group site or leaves the Company.

Responsibilities/Duties ??/?? 2:

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Change Analyst, have the responsibilities and permissions to update and manage the workflow of a change request or change order. Be responsible for:
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• Progressing Change Order through workflow stages.
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• Assuring that all required fields are populated and reconciling any issues during the process with originator.
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• Reviewing the change order for completeness and compliance with procedures. If acceptable, workflow will be moved to the next status. If unacceptable, workflow will be moved back to create change for the originator to resolve.
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• Manually moving the workflow to the next status once the change order has been fully processed.
• ??????????????????????????
• Reviewing Changes and rejecting if items submitted do not align with this SOP.
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• Assigning applicable Acknowledgers and approvers to the request per the Approval Matrix.
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• Reviewing all submitted COs and completition all implementation and release activities per governing procedure. per governing procedure
• ????????????????
• Confirmings training has been completed prior to release.
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• Entering in appropriate Effectivity Date for each item listed in the Affected Items tab.
• ????????????????????????
• Ensuring the Change is in alignment with quality system policies and procedures

Responsibilities/Duties ??/?? 3:

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Document Control. Maintain and organize the archived quality system documents and records. And compile the records index to keep the records easy to retrieve and find.
• ??????????????Agile?????????????????????
• Responsible for document archiving,release,storing and managing in Agile system or paper according to regulatory requirements and procedures.
• ???????????????????
• Coordinate external documents evaluation and maintain external document list.
• ????????????????????????
• Create or maintain document control/management related procedures/documents.
• ????????????
• Support quality management system audits.

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Other duties as assigned and/or contained in annual goals and objectives.

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This position is required to assure compliance of Company operations to all applicable laws, regulations and standards, good business practices and company documented procedures (including knowledge of all standards, government occupational health and environmental regulations and statutes related to the site).

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Engage others, promote, and participate in Environmental, Health, and Safety initiatives, focusing on continuous improvement.

Technical Knowledge and Skills ???????:
• ???????????????????
• College degree or above, major in technology related is preferred.
• ?????????????????
• Document management and QMS experience are preferred.
• ?????????????
• Above average command of English in reading and comprehension.
• ??????office???????
• Proficient in Office application.
• ??ISO13485?China MD GMP,EU MDD/MDR?????????????
• Knowledge in ISO13485, China MD GMP, EU MDD/MDR and experience in related responsibilities, preferred.

Abilities??:
• ????????????
• Strong communication skills, good logical thinking.
• ?????????????
• Ability to resolve change order and change request processing problems.
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• Ability to prioritize tasks and projects and work independently to meet assigned project deadlines.
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• Demonstrated ability to build effective business relationships and to handle confidential information properly.
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• Integrity and ethics. Detail oriented.

Planning and Decision Making?????:
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• Capable of making independent judgments that reflect excellent quality in daily work attributes
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• The person in this position is expected to prioritize daily activities based on workload and direction given by Manager/Supervisor.

Impact and Scope????? & Key Internal and External Relationships?????????:
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• Failure to follow regulation and procedures could result in non-compliance issues or finding during auditing.
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• Failure to update product documentation accurately can cause confusion and delays in production and other company operations. It could also cause noncompliance in a government and 3rd party audit.
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• Primary contact for employees and managers/supervisors in regard to training processes.
• ??????
• All related departments
Hangzhou Zhejiang China
Sr.Quality System Engineer ????????? Hangzhou Smiths Medical Hangzhou
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