Principal Engineer, Supplier Quality

SCIEX; Singapore; On-site; SGD 90,000 - 140,000; Full time

Job summary

SCIEX in Singapore is seeking a Principal Engineer, Supplier Quality, to drive supplier quality performance and ensure conformance to QARA requirements in a on-site role.

You will lead supplier qualification activities, support NPD/NPI projects with DFM reviews, PFMEA, and Quality Agreement approvals, and champion continuous improvement through data-driven problem solving across purchasing controls and supplier performance.

Qualifications

• 5-8 years of quality assurance/supplier quality experience in a manufacturing environment or regulated industry such as medical devices manufacturing.
• Experience with supplier audits and quality system requirements.
• ISO13485 or ISO9000 lead-auditor certification is a plus.
• Excellent verbal and written communication, organized, detail-oriented and strong leadership skills.

Responsibilities

• Manage the Mechanical and critical indirect Supplier portfolio and drive supplier quality performance to meet quality, delivery and business objectives.
• Lead supplier qualification activities for new/existing suppliers and support NPD/NPI projects through DFMs, PFMEA, Control Plan and Quality Agreement approval.
• Drive resolution of material quality issues through root cause analyses, implementing corrective actions and cross-functional problem solving.
• Act as SQE audit lead for internal/external audits (ISO9001/13485/GMP) ensuring compliance and timely closure of corrective actions.
• Develop and lead continuous improvement using problem-solving methodologies (8D, Fishbone, 5 Whys) on supplier quality processes and purchasing controls.

Skills

Quality assurance

Supplier quality

Auditing

Root cause analysis

Problem solving

Data analysis

Education

Bachelor's degree in Mechanical Engineering

Tools

ISO 9001

ISO 13485

PFMEA

Control Plan

Job description

Bring more to life.

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

At SCIEX, 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.

As part of SCIEX, you will help to influence life changing research and outcomes, while accelerating your potential. For more than 50 years, we have been empowering our customers to solve the most impactful analytical challenges in quantitation and characterization through ground-breaking innovation and outstanding reliability and support. You will be part of a winning team, enabled by DBS, that is passionate about helping life science experts around the world get to answers they can trust.

Learn about the Danaher Business System which makes everything possible.

The Principal Engineer, Supplier Quality is responsible for driving Quality performance of the suppliers to meet Sciex Product Quality requirements through supplier qualification processes, supplier control processes, aligned with supplier management strategies.

This position reports to the Senior Manager Supplier Quality and is part of the QARA team located in Singapore and will be an on-site role.

In this role, you will have the opportunity to:

• Manage the Mechanical and critical indirect Supplier portfolio, drive supplier quality performance to ensure compliance with quality, delivery, and business objectives.
• Lead supplier qualification activities for new and/or existing suppliers, support NPD/NPI projects through leading suppliers’ Design For Manufacturing (DFM) review, PFMEA, Control Plan and Quality Agreement approval per requirements.
• Drive resolution of material quality issues through deep-diving and challenging suppliers' root cause analyses, verifying corrective action and effectiveness, while driving cross-functional problem solving to seek optimal solution.
• Act as the SQE audit lead for internal/ external audits (ISO9001/13485/GMP), ensuring compliance, audit readiness, and prompt implementation and closure of corrective actions.
• Develop and lead continuous improvement by applying applicable problem-solving methodologies, such as fish-bone diagram, 8D, 5Why, or equivalent, on supplier quality processes, purchasing controls, and supplier performance monitoring systems to meet QARA requirements and business goals.
• Champion continuous improvement by leveraging data-driven problem-solving methodologies (e.g., 8D, Fishbone, 5 Whys) to strengthen supplier quality management, purchasing controls, and supplier performance, ensuring compliance and business success.

The essential requirements of the job include:

• Degree in Mechanical Engineering / Electro-Mechanical Engineering with at least 5-8 years’ experience in quality assurance/ supplier quality experience in a manufacturing environment or regulated industry such as medical devices manufacturing.
• Demonstrated experience on supplier audits. ISO13485 or ISO9000 lead-auditor certification is an added advantage
• Excellent verbal and written communication skills to all levels, organized, detail-oriented, and strong leadership skill.

Travel Requirements:

• Ability to travel – 20-30%, and maybe travel on short notice

It would be a plus if you also possess previous experience in:

• manufacturing operations and quality system practices with MDSAP environment