Senior QA Engineer


View: 104

Update day: 18-09-2023

Location: Singapore

Category: Production / Operation


Job type: Full-time

Salary: $4,600 - $5,200 a month

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Job content

Competency Requirements

  • Diploma/ B. Eng degree in Electrical, Electronic Engineering
  • Knowledge/Experience in Product development cycle, product qualification testing, including EVT and DVT, as well as PRT.
  • Experience in medical device industry for more than 2 years; experience in QMS with working knowledge of ISO13485, MDD, FDA QSR
  • Demonstrated knowledge of FMEA, DOE, DFSS, and problem-solving methodologies.
  • Knowledge of common programming languages.
  • Basic understanding of manufacturing processes.
  • Possesses good communication and analytical skills.
  • Ability to work cross-functionally with minimum supervision.
  • Ability to write quality procedures and technical documentation.
  • Knowledge in project management.
  • Prior knowledge of customer complaints handling would be preferred


1. Design Quality and Reliability Engineering

  • Develop and execute comprehensive product qualification plans to validate specification data.
  • Work closely with design engineers in DFMEA and DoE to ensure all specifications and quality goals are in place.
  • Risk assessment of Product Specification and Propose Quality Assurance Test Plan
  • Work closely with R&D, production plants, quality department, field service and other internal entities to highlight, support and resolve all design / process related problems in a timely manner that constantly meet customers’ product specifications and quality requirements.
  • Identify quality gaps, prepare and present quality and project reports, and make recommendations to address quality issues and to improve design margins and product robustness.
  • Work closely with the design team on a reliability program that includes, prediction modeling (MTBF/MCBF calculations), accelerated and life demonstration.
  • Develop component level and system integration test requirements, methodologies and processes.
  • Develop Manufacturing Quality plan to determine In-process/ Out-going test coverage to ensure product meet specification
  • Collaborate and coordinate with Testing Agency for Product Testing

2.Quality Assurance (QA)

  • Perform activities related to the documentation of Quality Management System (QMS) and ensure relevant processes and activities are in compliance with ISO13485, MDD 93/42/EEC, IVDD/98/79/EC, FDA21 CFR820, and other statutory or regulatory requirements in the capacity of Management Representation (MR);
  • Responsible for document control;
  • Prepare and co-ordinate both internal / external (including supplier) audits;
  • Provide QMS support to cross-functional teams, and ensure execution and effectiveness of key quality system processes;
  • Ensure design changes are tracked and process change requests in a timely manner;
  • Manage non-conformities (product and process) and track progress of resulting corrective action and preventive actions
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Deadline: 02-11-2023

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