东莞招聘

职位描述：
Supplier Quality Supervisor - Meter Operation

Reports to : Senior Quality Manager
Supervises : DCC/QS, (Senior) Quality Engineer

Responsibilities
Function as a technical liaison among Purchasing, Engineering, Operation and other departments to investigate, analyze and resolve quality problems by conducting audits, analyzing defect trends, develop corrective action plans to correct any process failings and leading continuous improvement projects. Maintain quality system to make sure its continuous effectiveness and meet all regulatory requirements. Lead quality system improvement.

Specific responsibilities include the following:
Quality Management and Process Improvement
Collect and evaluate quality data to identify process improvement opportunities
Create corrective action plans to address process failures and complete internal NCRs
Review manufacturing processes, collaborate with AMD team on process improvement and value enhancement opportunities.
Regularly communicate with Engineering, Quality Engineering, Production and Supply Chain internally to identify opportunities for Quality and Productivity improvement.
Collect and maintain AMD performance metrics.
Coordinate with Engineering and Manufacturing to ensure awareness to know product quality issue.
Assure AMD production team and QC understanding of product and submission requirements.
Participate in engineering change meeting to ensure the awareness on design changes. Ensure implementation is in accordance with first article process.
Review and approve quality plans on new part programs.
Regularly visit suppliers and assist Supply Chain in conducting Supplier Audits on Quality System and manufacturing processes, complete supplier visit report when required.
Resolves employee issues through problem resolution.
Supervision and personnel management, including employee hiring and firing, retention, performance appraisals, goal setting for group and individuals.


Quality System Maintenance and Improvement
QMS overhaul for the existing Quality System as to meet the ISO13485:2016 requirements.
Takes the leading role in the Internal Audit Program. Prepare annual internal audit plan, audit checklists, schedule and communicate with Process Owners, conduct and document the audit, follow up on corrective actions and review responses to ensure effective implementation. Summarize and present audit findings to (Senior) Quality Manager. Build out, train and supervise the performance of a team of internal auditors.
Takes the leading role in the establishment and maintenance of the Quality System and operating procedures to assure alignment with current GMP/QSR (21CFR820), ISO 13485 and CFDA GMP requirements.
Assist the (Senior) Quality Manager in all external audit activities conducted by third party or regulatory bodies.
Be the main contact person with CFDA regarding local regulation updates and compliance issues, licensing and registration activities. Be responsible for regular self inspection and adverse event monitoring and reporting to CFDA.
Conduct training and periodic refresher training in GMP/QSR (21CFR820), ISO 13485 and CFDA GMP requirements to staffs.
Document control to make sure it meets QMS and regulatory requirements.


Support Corrective Action Process
Participate in SRB meetings and present purchased part or product quality issue.
Perform or lead root cause analysis on product quality issues and work issue through containment phase of corrective action process effectively and timely.
Communicate and instruct AMD team on the use of corrective action process and quality tools & techniques.
Raise NCR/CAPA to record the internal/external nonconformance deviate against AMD Quality System.
Follow up NCR/CAPA status.

Responsible for all other duties as assigned.



Managed Areas include
Quality Performance
Quality System Compliance
NCR/CAPA
Internal Audits/External Audits


Qualifications

Required:
Bachelor degree in any science discipline.
3+ years or more experience in quality assurance for medical devices.
Strong understanding and practical experience in the medical device compliance requirements and regulations, e.g. current GMP/QSR 21CFR820, ISO 13485 and CFDA GMP.
Demonstrated competence in performing audits.
Strong experience in auditing design controls, design transfer, product validation and manufacturing operations will be a plus.
Ability to understand, review and document complex design issues.
Ability to effectively communicate technical findings to various subject matter experts.
Experience in addressing root cause and corrective actions and have good communication skills to work with process owner of the audit and agree upon the CAPA plan.
Ability to work on problems with limited direction.
Proficient with MS Office.
Excellent analytical and communication skills, both oral and written in English and Mandarin.
With hands-on experience in compliance field. 举报 分享

厂房面积超过8千平方公尺, 并拥有行业全套先进生产设备, 主要生产设备均由美国进口。

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