Quality Management

Dear Hiring Manager:

It is with great enthusiasm that I submit my application for the position of Supplier Quality Engineer for your organization. As a dedicated Quality Professional with over ten years’ extensive experience, I know my diverse skills and qualifications will make me an asset to your organization.

As you will see from the attached resume, I’ve built my career in a variety of roles and industries, all in MNC companies where I was not just an Engineer but also an expert in international management system in terms of ISO9001, ISO13485, and ISO14001 & OHSAS 18001, with an excellent track record in introducing improvements.

Key areas of expertise include:

Quality Control Tools

Quality Management System(ISO9001& ISO13845)

Environment Management System(ISO14001)

Health and Safety Management System(OHSAS 18001)

Good Manufacturing Practice(GMP)

CFR-Code of Federal Regulations Title 21

Lean Manufacturing

Supplier Management

Last but certainly not least, I am a

Warmest regards,

Xie Xianhua

Resume

Name: Xie Xian Hua

Address1: 144-63 37th Ave A3B Flushing NY

11354

Address 2: Block 17 Marsiling Lane, #12-247 Singapore 730017

Contact no: 859-***-****

(65) 9668 4572

E-mail address: ************@*****.***

Date of Birth: July 22, 1976

Nationality: Singaporean

Education

2007 – 2012 Bachelor of Technology (Industrial & Management Engineering)

National University of Singapore

2000 – 2003 Diploma in Manufacturing Engineering

Nanyang Polytechnic Singapore

Knowledge & Personal Attributes

Deployment of substantial skills in Statistical Analysis, Supplier Management – Leadership, Negotiation Skill, Audit & Project Management.

Proficient in Quality Assurance / Quality Analysis tools as 5D, SPC, PFMEA, MiniTab, etc, Strong problem solving skills.

Fluent English & Chinese in Listening, Speaking, Reading and Writing.

Strong communication, presentation and team skills, etc.

Proficient in use of MS Office software, Excel, Word, PowerPoint, Outlook.

Working knowledge of ERP system.

Professional Experience

3M Innovation Singapore, April 2013 to present

3M is a diversified technology company serving customers and communities with innovative products and services. Each of our five businesses has earned leading global market positions.

Supplier Quality Engineer II

Major Function

Support operations and engineering by identifying process improvement opportunities within designated supplier chain – Renewal Energy Division & Display Material & Systems Division. Working with the suppliers develop corrective action plans to correct any process failings and drive improvement in quality and productivity. Assist in all supplier qualification endeavours including driving endorsement of raw material/part specification, supplier audit and evaluation.

Responsibilities

Track & report supplier performance and quality to management. E.g. Supplier dppm.

Assist in all supplier qualification process- driving Incoming Quality Control for new materials/suppliers and establish raw material specification.

Lead Material Review Board (MRB) team to review Non-conformancing material, responsible to follow-up on the corrective actions requests, documentation/reports, tracking of internal excursions and to verify the effectiveness of corrective action plan.

Track and qualify or disqualify suppliers according to organization's standards.

Working with the supplier directly, create corrective action plans to address process failures and review non-conforming materials with cross-functional parties – supplier chain, engineering and manufacturing and regulatory department.

Collect and maintain supplier performance metrics and coordinate with Technical Support from Engineering, Manufacturing, Product Quality and Supplier Chain internally to identify opportunities for quality and productivity improvement.

Review supplier manufacturing processes, collaborate with suppliers on process improvement and value enhancement opportunities.

Regularly visit suppliers and drive Supplier onsite audit and evaluation.

Accomplishments

Successfully qualified several new critical material suppliers.

Successfully worked with supplier to identify and implement Kaizen projects to improve incoming quality control team’s productivity and efficiency.

Siltronic Samsung Wafer Pte Ltd, June 2012 to April 2013

Siltronic Samsung Wafer Pte. Ltd. is an exciting joint venture between Siltronic AG, a global leader in ultra-pure silicon wafers and Samsung Electronics, renowned for its inspired high technology innovations. It manufactures wafers of 300mm in diameter, currently the most advanced and largest diameter silicon wafers available for commercial mass production.

QA Engineer

Responsibilities

Track, report and handle internal excursions throughout Shift-book management system

Lead the Material Review Board(MRB) team, responsible to follow-up on the corrective actions requests, documentation/reports, tracking of internal excursions and to verify the effectiveness of corrective actions

Manage disposition of non-conforming products to assure good quality of shipped products and ensure the closure corrective and preventative actions

Support the company’s continuous improvement activities such as managing process changes and enhancing quality awareness

Review and monitor quality performance and generate COC for each shipment

Participate and involve in periodical audits and quality-relevant trainings

Participate in daily operations meeting to update inputs in quality aspect

Represent QA in weekly Wafering Breakage meeting & monthly Production Yield Meeting in order to report the investigation result and data analysis

Conduct FMEA review to assess the risk level for failure mode and / or the occurrence from each incident report according to AIAG standard

Responsible for any other duties a assigned i.e. preparing standard operation procedure(SOP) for Handling of Defect Category and participating in company’s continuous improvement projects

Accomplishments

Initialised a company’s continuous improvement project to improve IT system gap between two plants, which are used in different software about on-hold non-conforming semi-products from plant A to plant B

Successfully conducted/chaired MRB meetings to document the corrective, preventive actions including relevant FMEA review in 8D report

Successfully worked with cross-functional team to ensure the corrective and preventative actions to be cross-site closure and report the result to management team

Successfully established the communication channel to ensure the action items from MRB meeting minutes from plant A to be successfully implemented in plant B before the IT system improvement project is fully launched.

Successfully launched a new Standard Operation Procedure (SOP) – Handling of Defect Category, into Document Management System (DMS) in SAP, starting from drafting to final approval by management team.

Zuellig Pharma Specialty Solutions Group Pte Ltd, June 2010 – June 2012

Zuellig Pharma Specialty Solutions Group (SSG) is a pioneering regional consultancy and bio-logistic services division of Zuellig Pharma Asia Pacific. Strategically based in Singapore at the heart of Asia, SSG leverages Zuellig Pharma’s cutting-edge Regional Distribution Center (RDC) and pan-Asia coverage in 14 countries to provide customized, value-added bio-logistics for pharmaceutical, clinical trials, medical devices, diagnostics and other related companies.

QA Specialist

Responsibilities

Interact with production personnel in daily operations issues to reinforce the GMP practice & compliance

Review batch and quality documentations and conduct batch release

Follow-up any deviations related to regulatory and quality compliance with Principal before releasing products to the market

Provide QA assistance in deviation investigation, CAPA implement and Process Change control

Review SOP/Product Specification to ensure the feasibility of process required

Supervise, coach and develop a group of new QA personnel to achieve desired competencies

Lead the quality improvement project – Standardization of Retention Sample Process

Handle Clinical Trial Materials(CTM) to ensure in-bound CTM properly stored and out-bound CTM appropriately packed

Prepare and update standard operation procedures / work instructions for use within the organization when required

Conduct FMEA/risk assessment

Accomplishments

Successfully implemented the continuous project for Standardization of Retention Sample Process, starting from collection of Retention Sample to proper storage in warehouse.

Successfully lead and standardised QA process flow including two Sample Check, In-process and Final process check. And revised QA checklist to standardise the check content. And tidied up the product specification.

Successfully developed Training Materials to conduct training for new QA personnel

Sunningdale Tech Ltd, June 2005 – June 2010

Sunningdale Tech Ltd is a leading manufacturer of precision plastic components. The Group provides one-stop turnkey plastic solutions, with capabilities ranging from product design, mould fabrication, injection moulding and secondary processes, through to the precision assembly of complete products. Focusing on four key business segments – Automotive, Telecommunications, Consumer/IT and Healthcare – Sunningdale Tech has manufacturing facilities located in nine locations including Singapore, Malaysia, Indonesia, China and Mexico.

Quality System Assistant Engineer

Responsibilities

Reporting to Quality Assurance Manager, manage the integrated Quality (ISO9001, ISO13485), Environment, Health & Safety (ISO14001&OHSAS18001) management systems.

Conduct internal audit in different segments/businesses within the company, in Singapore and subsidiary plants with reference to various ISO standards (ISO9001, ISO/TS16949, ISO13485, and ISO14001 & OHSAS18001) and regulatory/customer requirements.

Ensure timely follow up of post audit activities by working closely with the respective internal team.

Facilitate an environment of continual improvement in the integrated management system, by interacting with representatives from all departments or through audits to regularly review the organization policies / procedures / processes, and initiate changes to ensure effective implementation of the integrated management system.

Lead and manage the Document Control activities and continually reviewing the adequacy and relevance of the documented procedures established, and implement necessary changes to improve the documentation process efficiency and effectiveness.

Conduct briefings / training on new / revised procedures / requirements to all relevant levels of company staff.

Accomplishments

Play a key role in implementing and qualifying the ISO13485 quality management system in subsidiary plant in JB, Malaysia, resulting in plant’s certification by SGS and one of Sunningdale’s customers from the healthcare segment (2009-2010).

Instrumental in the integration of the quality (ISO9001 & ISO13485) and environmental management systems (ISO14001) for the Medical and Consumer/IT divisions, resulting in increased effectiveness in system implementation, significant reduction in documentation and resources including the audit costs (2008 - 2009), and continual plant’s certification by various customers from different segments (2006 – present).

Assisted Corp QS Manager to organise the environment, health and safety (EHS) programs including field trips, resulting in significant improvements in increasing environmental consciousness, regulatory and EHS compliance and costs reduction (2007 – 2008).

NH Techno Glass(S) Pte Ltd May 2003 to June 2005

NH Techno Glass is a joint-venture between two industry leaders – Nippon Glass and Hoya, is the first mega facility from the leading Japanese thin film transistor (TFT) mother glass producer for producing specialized glass substrates for liquid crystal display (LCD) products. It has the full capability to support all of NH’s manufacturing needs including melting, forming, cutting and chamfering of glass substrates.

QA Officer

Responsibilities

Lead the Document Audit activity and train QC staff for incoming inspection

Instrumental in establishing the ISO9001 & ISO14001 management system

Conduct Internal Audit as per schedule

Liaise incoming quality issues with local and oversea suppliers

Involve in customer claim’s investigation and analysis

Prepare Product Standard/Specification for new products based on customers’ purchasing specifications

Prepare Customer QC report regarding of CPK trend and approval of COC

Compile and edit Monthly Quality Meeting Minutes

Use Minitab to generate SPC report

Accomplishments

Played a key role in implementing and qualifying the ISO9001& ISO14001 quality and environment management system, resulting in plant’s certification by PSB.

Implemented a Cost Reduction program by switching an overseas supplier to local supplier, starting from searching, selecting, evaluation and qualification of the local supplier.

Established Document Audit system to conduct document audit within the plant

Professional Development

2008 ISO22000:2005 Internal Auditor Training

SGS-SSC

2008 ISO/TS 16949:2002 Awareness Training

QEHS Simplicity Focus Consultants

2007 ISO 13485:2003 Internal Auditor Training

SGS-SSC

2006 Integrated QEHS Internal Auditor Training

ABS Quality Evaluations

2005 ISO9001:2000 Internal Audit

PSB Certifications

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