Quality Engineer - QMS

Flintex Consulting Pte Ltd; Singapore; On-site; SGD 50,000 - 61,000; Full time

Job summary

Flintex Consulting Pte Ltd is seeking a Quality Systems Manager to lead Asia quality initiatives and maintain the global quality system. You will develop, implement and maintain QMS documentation to ensure compliance with ISO 9001, ISO 13485 or GMP, and monitor regulatory changes.

Collaborating with Operations and Technology, you will drive continuous improvement, conduct internal audits, and prepare for external assessments.

Qualifications

• 4-6 years of quality management experience.
• Experience with ISO 9001, ISO 13485 or GMP preferred.
• Ability to conduct internal audits and support external audits.
• Strong communication and cross-functional collaboration skills.
• Willingness to travel overseas occasionally.

Responsibilities

• Develop, implement and maintain QMS documentation to meet quality standards.
• Monitor regulatory changes and update the QMS accordingly.
• Conduct internal audits and support external audits by bodies, suppliers, and customers.
• Analyze quality data to identify trends and drive improvements.
• Lead cross‑functional collaboration to embed quality into processes.
• Lead Management Review and act on follow-up items.
• Support training for staff in Quality Procedures, Standards and Tools.

Skills

Quality management

Auditing

Cross-functional collaboration

Data analysis

Communication skills

Education

Degree or equivalent

Certificate in Quality Engineering

Tools

MasterControl

PPAP

QIR

CCAR

SCAR

Job description

Job Information

Work Experience 4-5 years

SGD 4500 - SGD 5500

City Singapore

State/Province Central Singapore

079903

Job Description

Job Summary

Responsible for management of Asia Quality System, Policies, Programs and Initiatives. Part of the Global Quality Team to maintain global quality system and drive global initiative.

Role and Responsibilities

Quality System

• 1. Develop, implement and maintain QMS documentation to maintain compliance with applicable standards such as ISO 9001, ISO 13485 or GMP
• 2. Monitor regulatory changes and update the QMS accordingly
• 3. Conduct internal audits and support external audits (external auditing bodies, suppliers and customers)
• 4. Analyze quality data and metrics to identify trends and areas for improvement
• 5. Collaborate with cross functional teams to ensure that the quality standards are integrated into processes

Management Representative

• 1. Reports on QMS performance to top management and recommend improvement
• 2. Point of contact for certification bodies
• 3. Lead Management Review and follow up action items

Product Quality Management

• 1. Analyze and capture recurring product complaints, collaborate with Operation and Technology teams to address compound specified failures
• 2. Operational Quality Support. To facilitate continuous improvement initiatives, by providing on the floor support through use of quality tools and coaching teams to build ownership and proactive engagement with quality processes.

Customer Complaints Management

• 1. CCAR Manager. Manage the customer complaints handling process to ensure that all complaints are logged with right information for investigation till auditing process
• 2. Collaborate with cross functional team during the investigation, resolution and communication of customer complaints
• 3. Review interim CCAR reports to ensure that root cause is data driven and corrective action(s) address the root cause
• 1. SCAR Manager. Approve SCAR – Supplier related complaints and defects, review and monitor the effectiveness of corrective actions
• 2. Collaborate with Procurement, Supplier and internal stakeholders to investigate issues and resolution
• 3. Collaborate with Procurement, Operation and Technology to assess risk and quality impact of raw material on finished goods

Global Quality Team Collaboration

• 1. Support the implementation of global quality initiatives, systems and tools
• 2. Ensure that local QMS aligns with global practices and corporate policies
• 3. Share best practices and lessons learned across global sites

Support Quality Contracts/Documentation

• 1. Review customer documents and quality related agreements for compliances to ensure clauses are relevant, assess the risks.
• 2. Response to customer request for certifications, compliance/quality related/audit documents

System

• 1. Conduct training for staff in Quality Procedure, Standards and Tools.
• 2. Lead processes identified by the Global Quality Team such as PPAP, QIR, CCAR, SCAR and Mastercontrol for the Asia Region

Requirements

• Degree or equivalent experience in a field of study such as chemistry, business, accounting, engineering, etc.
• Certificate in Quality Engineering is preferred.
• 4-6 years of quality management experience. Junior with 1-2 experience in related field can also apply
• Demonstrates introductory understanding and ability and with guidance, applies competency in typical situations.
• Able to design quality systems to meet customer expectations and internal needs. New approaches and continuous improvement must be ongoing.
• Good experience into customer & supplier audit and able to conduct training
• Good interpersonal skills to be able to communicate and collaborate with all stakeholders and deal with situation proactively
• Occasionally overseas travel and weekly conference call is required for the role
• This position required to communicate closely with vendors in China.

Working hours

Mon to Fri 8.30am - 5.30pm ( 1 day hybrid )