Manufacturing/Ops Quality Engineer 1

ILLUMINA SINGAPORE PTE. LTD.; Singapore; On-site; SGD 40,000 - 60,000; Full time

Job summary

A leading biotechnology company in Singapore is seeking a Quality Assurance professional to support manufacturing operations and ensure compliance with regulatory standards. This role involves reviewing operational activities, managing quality issues, and collaborating with cross-functional teams. Ideal candidates have a Bachelor's degree in relevant fields and 0-2 years of experience in regulated environments.

Qualifications

• 0-2 years of related experience in manufacturing, quality assurance, and/or process validation.
• Familiarity with 21 CFR 820 and ISO 13485 requirements.
• Experience in the medical devices / IVD / biotech / pharmaceutical industry is an advantage.

Responsibilities

• Provide quality assurance support for manufacturing operations.
• Review operational activities for compliance with cGMP practices.
• Identify and drive resolution of quality issues in manufacturing operations.

Skills

Good interpersonal skills

Verbal communication skills

Written communication skills

Adaptability

Education

Bachelor's Degree in Biology, Biochemistry, Chemistry or equivalent

Tools

Word processing software

Spreadsheet software

Presentation tools

Job description

Position Responsibilities

• Provide quality assurance support for manufacturing operations, or field/ product quality.
• Review and align manufacturing operational activities, such as Work instructions, Device History Records, Nonconformances, CAPA, RMA, and customer complaint investigations.
• Ensure that facilities, equipment, materials, processes and product readiness comply with cGMP practices.
• Review verification and engineering study reports and identify gaps for GMP compliance. Develop and execute strategies to close gaps in an efficient, technical, and compliant manner
• Serve as Quality representative on project teams for reviewing the new product design transfers and/ or line transfers.
• Identify and drive resolution of quality issues in Quality Management System and/ or manufacturing operations.
• Work with cross-functional teams to resolve operational quality issues.
• Trend, analyze and monitor key performance indicators, suggest improvements and elevate to supervisor/ management as necessary.
• Participate in customer complaints and work closely with cross-functional teams to investigate issues and ensure timely response to corporate/ customer.
• Work in accordance with procedures and integrated program plans to achieve and maintain the required level of product quality in preparation for FDA and ISO third‑party audits.
• Support product risk management activities and ensure quality and completeness of project design history files, validation packages, and change orders.
• Coordinate issue resolution using a risk‑based approach.

Position Requirements

• Bachelor's Degree in Biology, Biochemistry, Chemistry or equivalent field is preferred.
• 0-2 years of related experience in manufacturing, quality assurance, and/ or process validation in a regulated environment.
• Experience in the medical devices / IVD / biotech / pharmaceutical industry, or instrument hardware / software integration is an advantage.
• Good interpersonal, verbal and written communication skills.
• Familiar with 21 CFR 820 and ISO 13485 requirements.
• Familiar with word processing, spreadsheets, and presentation tools.
• Familiar with failure investigation, technical report writing, data mining, trend analysis and statistical analysis.
• Adaptable to fast‑paced, dynamic work environment with shifting demands.
• Ability to operate with high level of independence to investigate and resolve compliance issues, lead projects, plan and implement improvements, and achieve goals.