Principal Supplier Quality Engineer

2 weeks ago


Singapore LEICA INSTRUMENTS (SINGAPORE) PTE LIMITED Full time

**Bring more to life.**

Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?

At Leica Microsystems, one of Danaher’s 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact.

You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact - innovating at the speed of life.

Shape the Future with Us

At Leica Microsystems, we have been shaping the future for over 175 years with groundbreaking optical and digital solutions. With a culture rooted in customer focus, innovation, and teamwork, we lead the market in microscopy, imaging, and analysis, unveiling the invisible and empowering our customers to build a better, healthier world.

Joining Leica Microsystems means contributing to scientific discoveries and supporting surgeons in making critical decisions. Our advanced microscopes and AI-based image analysis solutions enable users to gain profound insights into development and engineering challenges. Here, you will work on meaningful projects alongside passionate colleagues, driving progress and pushing the boundaries of what’s possible.

Learn about the Danaher Business System which makes everything possible.

The Principal Supplier Quality Engineer ensures the quality and reliability of supplied components through strategic supplier collaboration and risk-based oversight. This role drives supplier performance improvement, resolves complex quality issues, and ensures compliance with internal, customer, and regulatory standards. Key responsibilities include managing FAI and MRB processes, leveraging data for defect prevention and continuous improvement, and serving as a technical leader, audit representative, and mentor to ensure supplied materials consistently meet organizational and customer expectations.

This position reports to the Senior Manager, Supplier Quality and is part of the Regulatory Affairs and Quality Assurance department located in Singapore and will be an on-site role.

In this role, you will have the opportunity to:

- **Supplier Qualification and Lifecycle Oversight**
Qualify and approve direct and indirect suppliers of critical components/special processes to ensure consistent, compliant output. Maintain supplier status through rigorous quality system assessments, performance monitoring, and targeted corrective actions. Evaluate and approve supplier-initiated changes to safeguard conformance with specifications, customer expectations, and applicable regulatory standards. Conduct risk-based routine audits to verify adherence to contractual, customer, and regulatory requirements—driving sustained quality and reliability across the supply base.
- **Supplier Issue Resolution and Continuous Improvement**
- **FAI/MRB Leadership, Audit Representation & Quality Reporting**
Lead and govern the First Article Inspection (FAI) and Material Review Board (MRB) processes, ensuring timely execution, compliance, and effective disposition of nonconforming material. Represent the team during external and third-party audits or inspections, addressing inquiries related to supplier management, FAI, and MRB. Establish and standardize inspection methods, procedures, gauges, and measurement systems (e.g., MSA/GR&R) with suppliers. Provide clear reporting on supplier performance, quality trends, and systemic risks to management.
- **Leadership and Technical Guidance**
Representing Supplier Quality Engineering (SQE) in cross‑functional forums, aligning initiatives with organisational goals, and mentoring SQEs on quality practice, technical problem‑solving, and accountability. Govern critical quality activities, including engineering change impact/risk assessment, control plan reviews, customer complaint reviews, CAPA effectiveness, and inventory containment/traceability; ensure timely communication to suppliers and durable, long‑term effectiveness of actions.
- **Operational Excellence and Compliance**
Stay current with DBS tools such as 5S, DMP, SW, and TPI to promote sustainable continuous improvement. Ensure departmental compliance with the Quality Management System and Environment, Health & Safety (EHS) requirements, and address EHS concerns raised by associates.

The essential requirements of the job include:

- Degree in relevant Engineering discipline with 7 years of relevant working experience or Diploma in relevant Engineering discipline with 10 years of relevant working experience.
- Experience in supplier quality engineering within an assembly operations or engineering environment.
- Strong knowledge in various statistical control method and in QMS 9001.
- Familiar with ISO13485, USFDA QSR/cGMP (21 CFR Part 820) and ISO14971 for medical devices.
- Good understanding of metrology, Inspection Methods, Equipment and engineering drawings. Knowledge of measur


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