Quality Assurance Engineer

Randstad – Johnson & Johnson; Singapore; On-site; SGD 65,000 - 90,000; Full time

Job summary

Randstad – Johnson & Johnson is seeking a Quality Assurance Engineer on a 1 year contract in Singapore. You will ensure quality system compliance across service centers, drive CAPAs, audits, and continuous improvement while collaborating with cross-functional teams to deliver reliable outcomes for patients.

The role requires a bachelor’s degree in engineering and 3+ years in QA in a regulated medical device environment, with Lean Six Sigma or ASQ certifications considered a plus.

Qualifications

• Bachelor's degree in engineering or other technical field preferred with minimum 3 years of Quality Assurance experience.
• Experience in Medical Device environment preferred.
• Lean Six Sigma Green/Black Belt, Project Management Certification or ASQ certification (CIA, CQE) are an asset for this position.
• Experience in regulated ISO 13485 industries.

Responsibilities

• Be the main quality and compliance point of contact for assigned Service Center.
• Ensure QS procedures are followed at Service Site(s).
• Support audits, CAPAs, and nonconformances related to Installation and Services.
• Lead data-driven analysis and KPI tracking for quality performance.
• Coordinate CAPAs and audit observations with cross-functional teams.

Skills

Quality Assurance

Lean Six Sigma

CAPA handling

Regulatory knowledge

Education

Bachelors degree in engineering

Tools

ISO 13485

Job description

Quality Assurance Engineer 1 year contract, potential to renew

Come and join us!

Do you wish to work in a world-class organization trying your hands at something you have dreamt of doing?

“FIND YOUR PLACE” by joining a world-class MNC Healthcare company

Get an opportunity to explore new technology, learn new skills, enjoy the diverse and open culture, engagement and care, flexible working model, career opportunities, competitive salary and bonus, and endless amenities and benefits.

Company Description:

Our client is an MNC Healthcare company. As a focused healthcare company, with expertise in Innovative Medicine and MedTech, they are empowered to tackle the world’s toughest health challenges, innovate through science and technology, and transform patient care.

JOB SUMMARY

Make a meaningful impact on the quality and reliability of medical device service and repair. As the Staff Service Quality Engineer Service Quality, you will serve as a trusted quality and compliance partner for assigned Service Centers, helping teams consistently execute Quality System (QS) requirements and deliver dependable outcomes for customers and patients.

You will use data, risk-based thinking, and structured problem-solving to monitor performance, address nonconformances, CAPAs, and audit observations, and identify opportunities for continuous improvement.

DUTIES & RESPONSIBILITIES*

Be the main point of contact for quality and compliance aspects for assigned Service Center.

Ensure general compliance support for consistent and correct execution of QS procedures at assigned Service Site(s)

Ensure compliance of assigned Service site(s) to global and regional regulations, collaborating with Commercial Quality organization, supporting internal and external Audit

Collaborate with Service Operations to ensure global harmonization of service processes.

Collaborate with Customer Quality representatives to ensure compliance with reporting requirements of assigned Site(s) and accuracy of service evaluations linked to customer complaints.

Support tracking of monthly performance and quality metrics for assigned site(s).

Coordinate and support resolution for all nonconformances, CAPAs and audit observations related to Installation and Services.

Support procedures update and harmonization for global service alignment for sites.

Ensure the quality and compliance of service processes and record for CAPAs, Product Quality Escalations and any data analysis.

Ensure support in timely execution of CAPAs, Audit Observations, by cross collaboration across functions, sites and evaluating issues for resolution.

Support Service Sites internal and external audits based on sites requirements.

Conduct training related to procedural changes and coordinate with relevant stakeholders to investigate and document deviations identified at assigned sites.

Maintain awareness of FDA and ISO regulations while developing solutions to satisfy business needs.

Lead continuous improvement activities to ensure efficiency, effectiveness, and compliance of sites.

Support the deployment of KPIs and targets for projects deployed within Service.

Conduct data driven analysis based on requirements.

Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.

Can provide on the job training and procedural guidance to other Quality engineers.

Document, justify, review, or analyze whether a proposed change to a process will not enhance the risk level in some way beyond capability of current controls or whether change will result in potential non-compliance to a required standard

Performs other duties assigned as needed.

Qualifications, Experience and Competencies:

Bachelors degree in engineering or other technical field preferred with minimum 3 years of Quality Assurance experience

Experience in Medical Device environment preferred

Recommended Lean six sigma Green/Black Belt, Project Management Certification or ASQ certification (CIA, CQE) are an asset for this position.

Experience in regulated ISO 13485 industries.

What can I earn as a Quality Assurance Engineer