Senior QA Engineer

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

Responsibilities

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