Senior QC Leader, Biotech Diagnostics

Mirxes; Singapore; On-site; SGD 60,000 - 90,000; Full time

Job summary

MiRXES in Singapore is seeking a QC Supervisor to join the Quality team. You will oversee day-to-day QC operations, supervise staff, and ensure compliance with ISO13485 and regulatory requirements.

Responsibilities include material and finished product testing, data review, SPC analysis, nonconformance investigations, and supporting validation activities. Desired candidate has 4–5 years in QC within medical device manufacturing and GMP/ISO13485 experience, with qPCR knowledge.

Qualifications

• Diploma/Bachelor/Master in Biotechnology, Biochemical, Biochemistry, Analytical Chemistry, Molecular Biology/Life Science related courses.
• qPCR knowledge and experience with qPCR machines.
• Experience with laboratory testing and QC of assays-based workflows is advantageous.
• Able to work independently with minimal supervision and with others.
• Excellent organizational and time management skills.
• 4–5 years of relevant experience in quality control; medical device manufacturing experience preferred.
• GMP and ISO 13485 experience would be beneficial.

Responsibilities

• Manage team performance, including training, competency assessments and ensuring the technical proficiency of QC staff.
• Supervise QC Specialists and Technicians to ensure smooth execution of routine QC operations.
• Plan and schedule daily QC routine and ad hoc testing.
• Oversee QC lab housekeeping, including cleanliness, equipment maintenance, documentation archival, and reagent inventory tracking.
• Perform routine QC testing of raw materials, in-process materials and finished goods.
• Evaluate data, draft and/or review QC reports, highlighting deviations from standard operating procedures.
• Perform trend analysis and utilize SPC tools to identify process anomalies and prevent failures.
• Troubleshoot QC failures and raise nonconformance reports; investigate root causes.
• Support validation and stability studies for lab development and diagnostic products as needed.
• Ensure all lab activities and documentation comply with ISO13485 and regulatory requirements.
• Draft and update QC work instructions and contribute to continuous improvement of workflows.
• Apply good documentation practices on all records for traceability and auditing.
• Perform any other duties as assigned.

Skills

qPCR knowledge

Laboratory testing

Documentation & record-keeping

People management

Analytical thinking

Education

Biotechnology/Life Sciences degree (Diploma/Bachelor/Master)

Job description

MiRXES in Singapore is seeking a QC Supervisor to join the Quality team. You will oversee day-to-day QC operations, supervise staff, and ensure compliance with ISO13485 and regulatory requirements.

Responsibilities include material and finished product testing, data review, SPC analysis, nonconformance investigations, and supporting validation activities. Desired candidate has 4–5 years in QC within medical device manufacturing and GMP/ISO13485 experience, with qPCR knowledge.