QA Engineer (Onsite)

• →Quality System Development & Compliance:
  Partner with the QA Manager to establish, optimize, and sustain the site’s QMS in alignment with ISO 9001:2015 and other applicable standards. Drive adherence to quality policies and ensure system effectiveness across all operational areas.
• →CAPA & Root Cause Analysis:
  Lead end-to-end Corrective and Preventive Action (CAPA) processes — including investigation, root cause analysis (using tools such as Fishbone, 5 Whys), implementation of corrective measures, and verification of effectiveness.
• →Audits & Inspections:
  Conduct internal audits, perform supplier audits, support regulatory inspections, and carry out routine on-site quality inspections to ensure compliance and identify improvement opportunities.
• →Document Control & Review:
  Review, approve, and maintain controlled documents including SOPs, forms, test plans, and validation protocol/report. Ensure documentation reflects current best practices and regulatory expectations.
• →Change & Deviation Management:
  Support and review Engineering Change Orders, Document Change Controls, and Deviations to ensure compliance with SOPs, proper risk assessment, and timely implementation.
• →Risk Management:
  Actively participate in risk assessments, Failure Mode and Effects Analysis (FMEA), and implementation of risk mitigation strategies to proactively address potential quality issues.
• →Compliance Monitoring:
  Monitor and drive timely closure of CAPAs, completion of training requirements, handling of Non-Conforming Materials (NCMs), and other key QMS metrics to ensure ongoing compliance.
• →Data Analysis & Continuous Improvement:
  Analyze quality performance data (e.g., defect rates, audit findings, complaint trends) to identify systemic issues and lead or support continuous improvement projects.
• →Product Complaints & NCM Handling:
  Participate in investigations related to customer complaints, product returns, and non-conforming materials — ensuring appropriate containment, correction, and preventive actions are taken.
• →Training & Competency Development:
  Develop, deliver, and maintain quality training programs for new hires and existing staff. Ensure personnel competency aligns with QMS requirements.
• →Ad Hoc Assignments:
  Perform other duties and special projects as assigned by the QA Manager to support business and quality objectives.

• Education: Bachelor’s degree in Engineering, Biomedical Sciences, Life Sciences, or a related technical field.
• Experience: Minimum 2 years of hands-on experience in quality assurance, preferably within an ISO 9001-certified environment or manufacturing/QA site management role.
• Certifications (Preferred): ISO 9001:2015 Internal Auditor certification is a strong advantage.
• Technical Skills: Proficient in quality tools and methodologies (e.g., CAPA, FMEA, Root Cause Analysis, Statistical Process Control). Familiarity with document control and change management systems.
• Soft Skills: Strong analytical, problem-solving, and communication skills. Highly detail-oriented, self-motivated, and able to thrive in a fast-paced, dynamic environment. Demonstrated ability to manage multiple priorities with minimal supervision.
• Language: Fluency in English (written and spoken) is required. Proficiency in Mandarin Chinese is a distinct advantage for cross-regional collaboration.

This is a fully onsite position based in Singapore.