- Singapore
Full Time Production Quality Engineer (Medical Device) Jobs, Salary up to SGD 5,000 in Dart Solutions - Maukerja
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Production Quality Engineer (Medical Device) – Singapore
Singapore | Quality Engineering | Medical Devices | Manufacturing | Production | Quality Assurance| ISO13485 | ISO 14971 | IQ/OQ/PQ | GMP | FDA QMSR
Salary up to SGD 5,000/month
About the Role
A growing medical device manufacturing team in Singapore is looking for a
Production Quality Engineer
to support production quality, process improvement, validation, and quality management activities.
This is a hands-on role focused on investigating manufacturing issues, driving corrective actions, improving process capability, and maintaining product conformity within a regulated medical device environment. Ideal for someone who enjoys working closely with
Production and Engineerin
, solving practical manufacturing problems, and driving continuous improvement.
About the Company
The company is a Singapore-based contract manufacturer supporting global
medical device OEMs
and operates within a regulated manufacturing environment. With
ISO 13485:2016
certification and strong manufacturing capabilities, the organization supports customers across production quality, process validation, quality improvement, and medical device manufacturing.
What’s in it for you
Hands-on exposure to
medical device manufacturing and production quality
Work closely with Production, Engineering, and customers
Exposure to
CAPA, validation, risk management, and quality audits
Develop experience with
ISO 13485, GMP, and FDA QMSR
requirements
Gain practical experience in
SPC, MSA, FMEA, and root-cause analysis
Participate in
Lean / Kaizen continuous improvement initiatives
Opportunity to develop a long-term career in medical device quality engineering
What you’ll be doing
Lead investigations into product and process
non-conformances
Conduct root-cause analysis using
5 Whys, Fishbone, and FMEA
Drive
CAPA
and verify the effectiveness of corrective actions
Support
IQ/OQ/PQ validation
of equipment, processes, and test methods
Work with Production to resolve manufacturing failures and quality issues
Monitor process capability, stability, yield, and defect performance
Apply quality tools including
SPC, MSA, and FMEA
Drive
Lean / Kaizen
and continuous improvement activities
Support internal, customer, and regulatory audits
Prepare quality metrics, trend analysis, and management reports
Support risk management activities in accordance with
ISO 14971
What we’re looking for
Diploma or Degree in
Mechanical, Biomedical, Manufacturing Engineering
, or related discipline
Experience in
medical device manufacturing or another regulated industry
Understanding of
ISO 13485, GMP, and FDA QMSR
requirements
Experience with process validation and manufacturing quality tools
Practical knowledge of
CAPA, FMEA, SPC, MSA, and root-cause analysis
Strong analytical and problem-solving skills
Good communication and cross-functional collaboration skills
Experience with customer audits, supplier quality, or
Lean Six Sigma
is an advantage
Comfortable working closely with Production and Engineering in a fast-paced manufacturing environment
Able to work independently while collaborating effectively with cross-functional teams
Dart Solutions was founded in 2017 with a mission to allow our clients access to our large network and database of professionals and top talents across industries and sectors within the Marine, Engineering, IT & Digitalization, Sales & Marketing and a suite of other corporate services helping them find the best talents possible. Everything the market needs, we've got it covered. All your hiring needs in one place.
From permanent, interim and contract recruitment to executive searches, our suite of services and expertise has helped many companies of all sizes hire with confidence the best they need, when they need it.
With strategically located headquarters springing up in Singapore overlooking the Asia Pacific, you can be assured our area of coverage, expertise and the people in our network has always extended beyond the shores of Singapore spanning across the entire Asia Pacific, ensuring our clients and candidates receive the best service, advice and results, always.
Singapore | Quality Engineering | Medical Devices | Manufacturing | Production | Quality Assurance| ISO13485 | ISO 14971 | IQ/OQ/PQ | GMP | FDA QMSR
Salary up to SGD 5,000/month
About the Role
A growing medical device manufacturing team in Singapore is looking for a
Production Quality Engineer
to support production quality, process improvement, validation, and quality management activities.
This is a hands-on role focused on investigating manufacturing issues, driving corrective actions, improving process capability, and maintaining product conformity within a regulated medical device environment. Ideal for someone who enjoys working closely with
Production and Engineerin
, solving practical manufacturing problems, and driving continuous improvement.
About the Company
The company is a Singapore-based contract manufacturer supporting global
medical device OEMs
and operates within a regulated manufacturing environment. With
ISO 13485:2016
certification and strong manufacturing capabilities, the organization supports customers across production quality, process validation, quality improvement, and medical device manufacturing.
What’s in it for you
Hands-on exposure to
medical device manufacturing and production quality
Work closely with Production, Engineering, and customers
Exposure to
CAPA, validation, risk management, and quality audits
Develop experience with
ISO 13485, GMP, and FDA QMSR
requirements
Gain practical experience in
SPC, MSA, FMEA, and root-cause analysis
Participate in
Lean / Kaizen continuous improvement initiatives
Opportunity to develop a long-term career in medical device quality engineering
What you’ll be doing
Lead investigations into product and process
non-conformances
Conduct root-cause analysis using
5 Whys, Fishbone, and FMEA
Drive
CAPA
and verify the effectiveness of corrective actions
Support
IQ/OQ/PQ validation
of equipment, processes, and test methods
Work with Production to resolve manufacturing failures and quality issues
Monitor process capability, stability, yield, and defect performance
Apply quality tools including
SPC, MSA, and FMEA
Drive
Lean / Kaizen
and continuous improvement activities
Support internal, customer, and regulatory audits
Prepare quality metrics, trend analysis, and management reports
Support risk management activities in accordance with
ISO 14971
What we’re looking for
Diploma or Degree in
Mechanical, Biomedical, Manufacturing Engineering
, or related discipline
Experience in
medical device manufacturing or another regulated industry
Understanding of
ISO 13485, GMP, and FDA QMSR
requirements
Experience with process validation and manufacturing quality tools
Practical knowledge of
CAPA, FMEA, SPC, MSA, and root-cause analysis
Strong analytical and problem-solving skills
Good communication and cross-functional collaboration skills
Experience with customer audits, supplier quality, or
Lean Six Sigma
is an advantage
Comfortable working closely with Production and Engineering in a fast-paced manufacturing environment
Able to work independently while collaborating effectively with cross-functional teams
Dart Solutions was founded in 2017 with a mission to allow our clients access to our large network and database of professionals and top talents across industries and sectors within the Marine, Engineering, IT & Digitalization, Sales & Marketing and a suite of other corporate services helping them find the best talents possible. Everything the market needs, we've got it covered. All your hiring needs in one place.
From permanent, interim and contract recruitment to executive searches, our suite of services and expertise has helped many companies of all sizes hire with confidence the best they need, when they need it.
With strategically located headquarters springing up in Singapore overlooking the Asia Pacific, you can be assured our area of coverage, expertise and the people in our network has always extended beyond the shores of Singapore spanning across the entire Asia Pacific, ensuring our clients and candidates receive the best service, advice and results, always.
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