Senior Quality Manager

Beyonics Pte Ltd; Singapore; On-site; SGD 80,000 - 120,000; Full time

Job summary

A leading company in the manufacturing sector seeks a Senior/Quality Manager responsible for developing and maintaining the Quality Management System compliant with regulatory standards. The successful candidate will drive quality improvements, oversee audits, and ensure product quality while providing leadership to the quality team.

Qualifications

• Minimum 10 years of experience in quality assurance/control in manufacturing.
• Thorough knowledge of ISO 13485, FDA requirements, and GMP standards.
• Strong understanding of injection molding processes.

Responsibilities

• Develop and maintain Quality Management System processes and documentation.
• Conduct internal and external quality audits.
• Manage the site's Quality System including CAPA and document control.

Skills

Leadership

Problem Solving

Process Analysis

Quality Assurance

Quality Control

Education

Bachelor's degree in Science or Engineering

Tools

Microsoft Office

FMEA

MSA

DOE

SPC

Job description

Main role:

Responsible for the development, implementation, and maintenance of the Quality Management System (QMS).

The Senior/Quality Manager serves as the quality figurehead for the site, driving a culture of compliance, responsiveness, and data-driven decision-making. The role involves ensuring the quality team is well-structured and providing guidance to reporting personnel.

JOB REQUIREMENTS / RESPONSIBILITIES

Quality Compliance

• Establish, implement, and maintain processes and documentation for the QMS according to ISO 13485 and FDA 21 CFR 820 standards for medical business, IATF 16949 for automotive, and ISO 9001 for technology.
• Manage, plan, and perform internal and external quality audits to ensure compliance.
• Report QMS performance regularly to executive management.
• Manage the site's Quality System, including CAPA, deviations, nonconformance, document control, supplier quality, complaints, and audits.
• Promote awareness of regulatory and customer requirements and ensure organizational compliance.
• Host regulatory and customer quality audits.
• Collaborate with suppliers to improve product quality and resolve issues, including supplier audits.
• Review and approve suppliers of components, raw materials, and services affecting product quality, and assist in supplier certification.
• Develop and implement site-wide GMP and related training programs to enhance quality awareness.
• Ensure compliance with ISO 14001 and other environmental regulations.

Quality Operations

• Ensure timely release of finished products after testing and inspection.
• Participate in planning and executing new product introductions, including validation and qualification strategies.
• Use problem-solving techniques to resolve product/process issues and implement improvements.
• Utilize data for decision-making, focusing on performance metrics for preventative and corrective actions.
• Drive continuous quality improvements and participate in cross-functional projects.
• Maintain complete and accurate quality records and ensure effective quality control operations.

1. Oversee discrepancies or non-conforming products/materials, leading investigations and collaborating on dispositions.

• Serve as the quality contact for customer audits, complaints, and product issues.
• Develop and ensure the effectiveness of corrective and preventive actions.
• Lead cross-functional teams to resolve quality issues to meet plant goals.
• Provide leadership on QA matters, including quality systems, compliance, and material disposition.
• Adhere to safety and environmental standards and policies.
• Perform any other assigned tasks.

EDUCATION / ACADEMIC QUALIFICATION

• Bachelor's degree in Science or Engineering (e.g., Biomedical, Mechanical, Mechatronics, Chemical, Polymer, Industrial, Quality Management).

KEY REQUIRED EXPERIENCE, SKILLS, AND ABILITY

• Minimum 10 years of progressive experience in quality assurance and control in manufacturing or equivalent.
• Thorough knowledge of ISO 13485, FDA 21 CFR Part 820, Medical Device Directives, ISO 16949, and GMP requirements.
• Strong understanding of injection molding processes and tooling.
• Proficiency in Microsoft Office and engineering tools (FMEA, MSA, DOE, SPC, etc.).
• Skills in process analysis, problem solving, and process improvement using Lean Manufacturing methods.
• Ability to support product development, manufacturing, and release activities as directed by senior management.