Senior QA Engineer at 10x

, , Singapore -

Full Time

Start Date

Immediate

Expiry Date

27 Jan, 26

Salary

0.0

Posted On

29 Oct, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Assurance, Supplier Quality Management, Root Cause Analysis, Corrective Action, Continuous Improvement, ISO 9001, ISO 13485, CAPA Management, Data Analysis, Electro-Mechanical Systems, Instrumentation, Manufacturing Processes, Collaboration, Problem Solving, Quality Metrics, FMEA

Industry

Biotechnology Research

Description

New Product Transfer Collaborate with R&D and Engineering to ensure product meets quality, manufacturability and reliability requirements from pilot build through production Provide quality oversight and guidance to internal teams and contract manufacturers throughout new product introduction and production transfer Participate in build readiness reviews, risk assessments, and issue resolution to ensure a seamless transition from pilot to full production Supplier Quality Management Partner with contract manufacturers and key suppliers to ensure product and process quality meet requirements Assess, develop, and continuously improve supplier quality systems, driving alignment to company expectations and quality standards (ISO 9001/13485) Conduct supplier audits, process reviews and performance monitoring using quality metrics and KPIs Lead root cause analysis and corrective action implementation for supplier-related issues, including SCAR management Build strong collaborative relationships with suppliers to foster a culture of quality ownership and continuous improvement Manage Quality Operations Lead investigation and resolution of nonconformances, deviations, and manufacturing issues reported from internal production teams Partner with contract manufacturers and suppliers on failure analysis and corrective actions Support customer complaint investigations related to instruments, ensuring timely containment, root cause identification and CAPA implementation Drive ongoing quality improvements in instrument assembly processes both in-house and at suppliers Continuous Improvement Support development and continuous enhancement of quality procedures, documentation,and control processes Track and analyze key quality metrics to identify trends and drive preventive actions Support internal and external audits, qualification, and regulatory compliance efforts Lead and participate in cross-functional quality improvement projects to strengthen product reliability and process robustness Bachelor's degree in Mechanical Engineering (or equivalent) Demonstrable experience in complex instrumentation or electro-mechanical system manufacturing within the Life Sciences or Medical Device industry Strong technical understanding of precision assemblies, motion systems (X-Y stage), instrument fixtures and testing tools Proven experience working with contract manufacturers and managing supplier quality and performance including participation in NPI cycles Experience in supplier development or Supplier Management/Vendor quality system enhancement Understanding of ISO 9001 and/or ISO 13485 quality management system requirements Knowledge of CAPA, nonconformance, deviation and SCAR management Strong problem-solving and analytical skills, with a track record of driving quality and process improvements Excellent communication and collaboration skills with cross-functional partners Professional quality certification such as CQE, CQA or Six Sigma Green/Black Belt Knowledge of software and firmware integration testing in complex instruments Proficiency with data analysis and quality tools (e.g. 8D, FMEA, SPC, Pareto)

Responsibilities

The Senior QA Engineer will collaborate with R&D and Engineering to ensure product quality during the transition from pilot builds to full production. They will also manage supplier quality and lead investigations into nonconformances and manufacturing issues.