QA Engineer

Fluidigm; Singapore; On-site; USD 60,000 - 90,000; Full time

Job summary

Join a forward-thinking company dedicated to advancing human health as a QA Engineer. In this role, you will manage product quality issues, analyze data to drive improvements, and ensure compliance with ISO 13485 standards. Collaborate with engineering and manufacturing teams to enhance product quality and participate in internal audits. This position offers a dynamic environment where you can contribute to meaningful advancements in life sciences. If you are a proactive problem solver with a passion for quality assurance, this is the perfect opportunity for you!

Qualifications

• 2-3 years of QA experience in medical device manufacturing.
• Knowledge of ISO 13485 quality system requirements.

Responsibilities

• Manage product quality issues and analyze quality monitoring data.
• Participate in internal audits and support new product transfers.

Skills

Problem Solving

Analytical Skills

Communication Skills

Customer Focus

Education

Bachelor’s Degree in Engineering

Bachelor’s Degree in Science

Bachelor’s Degree in Biotechnology

Tools

eQMS software

Microsoft Excel

Microsoft Office

Job description

Job Description

Would you like to join an innovative team driven by a bold vision –unleashing tools to accelerate breakthroughs in human health?

It is an extraordinary time for Standard BioTools. Our technology is empowering customers to improve life through comprehensive health insight. We invite you to join a leading provider of indispensable life sciences tools that is accelerating global research on multiple frontiers of human health.At Standard BioTools, we are building a positive culture where our people can do the best work of their careers, informed, and influenced by our core behaviors:

• Keep customers front and center in all of our work
• Be accountable and deliver on commitments
• Drive continuous improvement
• Be collaborative and work as one team: fostering communications in a learning, coaching, and helpful environment

Standard BioTools is looking for QA Engineer reporting to the QA Manager in our Singapore plant.

Description:

• Manage product quality issues according to the requirements of the Quality System.
• Analyze quality monitoring data and trend performance to drive product quality improvement in collaboration with Engineering and Manufacturing.

• Review batch and quality records and approve QA release for finished goods.
• Review records of Non-conformances to ensure proper documentation of disposition, investigation results and follow up of actions.
• Participate in investigation and implementation of corrective and preventive actions for non-conformities or the other non-compliance issues in manufacturing or quality system processes and follow up on proper closure with verification of effectiveness.
• Participate in internal audits.

• Support activities to ensure successful transfer of new products into manufacturing.
• Support Document Control/ Quality System activities using eQMS software.

• Develop and maintain procedures and support other duties as assigned.

Qualifications Include:

• Bachelor’s Degree in Engineering, Science, Biotechnology or related fields.
• Minimum 2- 3 years’ experience in QA in medical device manufacturing or related industry.
• Knowledge and understanding of ISO 13485 quality system requirements.
• Good problem solver with initiative, resourcefulness, analytical skills and a customer-focus attitude.
• Knowledge of manufacturing processes and process control principles; including FMEA, problem solving tools, statistical methods.
• Good communication and interpersonal skills
• Proficiency in Microsoft Excel/Office and other software to analyse data and generate reports.

Ready to join an industry leader with a bold and ambitious mission that is enabling advancements in human health? Apply online with your resume!

US/Global:

Standard BioTools is an equal opportunity/affirmative action employer. We will consider all qualified applicants for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.