Quality Engineer Medical Device jobs

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We’re Hiring: P

roduction Quality Engineer (MD) | Medical Device Manufacturing

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Singapore

– West | Full-Time, Permanent

Are you a Quality Engineer who enjoys being close to production, solving real manufacturing problems and driving improvements?

AMT Pte Ltd

, a Singapore-based ISO 13485:2016 certified contract manufacturer supporting global medical device OEMs, is looking for a Production Quality Engineer to join our team.

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What you’ll work on

Lead investigations into product and process non-conformances using 5 Whys, Fishbone, FMEA and structured root-cause analysis

Drive CAPA and ensure corrective actions are effective and sustainable

Support IQ/OQ/PQ validation of equipment, manufacturing processes and test methods

Partner with Production to resolve failures, analyze data and maintain product conformity

Monitor and improve process capability, stability, yield and defect performance

Apply quality tools including SPC, MSA and FMEA

Drive continuous improvement and Lean/Kaizen initiatives

Support internal, customer and regulatory audits

Prepare quality metrics, trend analysis and management reports

Support risk management activities in accordance with ISO 14971

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Who we’re looking for

Diploma/Degree in Mechanical, Biomedical, Manufacturing Engineering or related discipline

2–5 years' experience in medical device manufacturing or another regulated industry

Good understanding of ISO 13485, GMP and FDA QMSR requirements

Experience in process validation, statistical analysis and manufacturing quality tools

Strong analytical, problem-solving and communication skills

Comfortable working cross-functionally in a fast-paced manufacturing environment

Experience with customer audits, supplier quality or Lean Six Sigma will be an advantage.

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Why join us

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This is a hands-on quality engineering role where you’ll work directly with Production, Engineering and customers to solve practical manufacturing challenges and improve the processes behind medical device products.

You’ll gain exposure across production quality, validation, CAPA, risk management, audits and continuous improvement — building a strong foundation for a long-term career in medical device quality and manufacturing.

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What we offer

Competitive salary based on experience, performance bonus and medical benefits.

If you’re looking to move beyond routine quality inspection and develop into a well-rounded Quality Engineer in a regulated manufacturing environment, we’d like to hear from you.

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Interested

? Apply or reach out to us to learn more.

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AMT Pte Ltd (“AMT”) is the Medical Contract Manufacturing arm of Advanced MedTech.

At AMT, our goal is to be your strategic contract manufacturing partner to help you deliver more innovative and effective solutions.

Through our advanced 3D metal prototyping and Metal / Ceramic Injection Molding technologies, we help bring designs to life for market leaders in the Medical, Industrial, Automotive and Electronic industries. By vertically integrating our Class 10,000 clean room and ETO sterilization capabilities, it enables us to offer a broad range of medical surgical and procedural kitting solutions.

We do business across 30 over countries and are made up of 350 passionate employees dedicated to advancing manufacturing possibilities to help you and your organization bring ideas to life.