Quality Control Engineer

RECRUIT EXPRESS PTE LTD; Singapore; On-site; SGD 60,000 - 75,000; Full time

Job summary

A leading recruitment agency is seeking a Quality Control Specialist in Singapore to ensure compliance with operational procedures and regulations. Responsibilities include designing test specifications, managing supplier quality, and leading audits. Candidates should have a technical degree and several years of experience in Quality Control within a regulated environment. Application process involves submitting a resume to the specified email.

Qualifications

• 5-7 years of relevant experience in Quality Control, preferably within a regulated environment.
• In depth knowledge of QMS regulations: ISO 13485, 21 CFR 820.
• ISO 9001/13485 auditor experience or certification.

Responsibilities

• Oversee inspection and operational processes to ensure compliance.
• Create test specifications and measurement programs.
• Collaborate on design of fixtures and jigs.

Skills

Quality Management Systems (QMS)

Regulatory Compliance

Data Analysis

Supplier Management

Problem Solving

Education

Technical/scientific degree in mechanical/mechatronic engineering

Tools

SAP

Success Factor

Job description

Responsibilities

• Ensure Process Compliance: Oversee inspection and operational processes to ensure adherence to established procedures, work instructions, drawings, and specifications.
• Develop Test Specifications and Programs: Create test specifications and measurement programs for geometric and non-geometric tests, including material testing devices (e.g., tensile-testing).
• Support Fixture and Jig Design: Collaborate with internal and external service providers to design and construct fixtures and jigs, including concept development and requirement specification creation.
• Validate Measurement Procedures: Perform method validation and verification of measurement procedures in compliance with existing regulations and guidelines, including conducting GR&R (Gauge R&R) and process capability studies.
• Manage Test Equipment Selection and Procurement
• Integrate Testing Systems
• Streamline Incoming Material Processing
• Oversee incoming rejection processes for non-conforming materials, monitor aging periods, and implement actions to minimize delays and inventory impact.
• Collaborate on Inspection Requirements: Work with the quality or engineering team to define incoming inspection and metrology requirements for new products and raw components.
• Analyze and Report Quality Performance Data: Lead quality inspection performance data analysis, establish KPI metrics, and report findings to drive improvements.
• Coordinate and work on the Supplier Selection process for new project development and qualification of new and or alternate supplier, to ensure that the right supplier is selected based on the defined requirements and specifications.
• Supports and or lead the conceptualized bill of materials creation together with relevant functions for new product development.
• Resolve supplier-related quality issues by ensuring timely and effective resolutions to maintain continuity of supply. Proactively collaborate with suppliers to identify opportunities for improvement, implement controls, and enhance the quality of received materials.
• Oversee Supplier Quality Management activities
• Support suppliers change requests and qualification initiatives
• Review and approve supplier control plans and inspection standards
• Ensure timely resolution of supplier quality issues
• Establish and maintain Supplier Quality Agreements, ensuring clarity in expectations and adherence to standards.
• Lead supplier audits (desktop, remote, or onsite) as part of the Global Supplier Audit program by developing comprehensive audit agendas, conducting thorough evaluations, preparing detailed supplier audit reports, and ensuring supplier adherence to quality and regulatory standards.

Requirements

• Technical / scientific degree at college / university level (mechanical, mechatronic engineering or equivalent)
• 5-7 years of relevant experience in Quality Control, preferably within a regulated environment.
• In depth know-how of QMS regulations: ISO 13485, 21 CFR 820, ISO 14971, or applicable local regulations.
• ISO 9001/13485 auditor experiences or certification
• SAP and Success Factor User experience is a plus

Qualified candidates are invited to submit their applications in (MS Word) format to

to Shaun Quek Yew Meng R1660732

[e-mail]

Recruit Express Pte Ltd

EA Licence No: 99C4599

Only shortlisted applicants will be notified.