Principal Engineer Supplier Quality(SQE)

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 Danahers 15 operating companies our work saves livesand were all united by a shared commitment to innovate for tangible impact.

Youll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danahers 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 Shanghai supports manufacturing in Beijing and will be an on-site role

In this role you will have the opportunity to:

• Lead supplier qualification activities for new suppliers with Global Sourcing & Global Supply Chain.
• Monitor supplier performance review periodic quality data/reports/scorecards and related action plans.
• Drive resolution of complex material quality issues through root cause analysis and close collaboration with suppliers to ensure timely corrective actions including leading failure analysis and comprehensive resolution of defective parts (factory and field).
• Lead Continual Improvement initiatives / activities such as Kaizen to improve KPIs e.g. work together with supplier on using PSP to identify critical few for proper root cause investigation & Poka-yoke solution.
• Support and participate in internal audits and ISO9001 ISO13485 and GMP/FDA compliance activities while contributing to supplier quality strategy planning and driving improvement initiatives.
• Ensure China site compliance with ISO9001 ISO13485 FDA 21 CFR Part 820 and China NMPA requirements and support and lead internal and external audits including preparation execution and timely closure of audit findings.
• Any agreed-to works by superiors.

The essential requirements of the job include:

• Degree in Electrical/Electronics/Mechanical Engineering with of 5-8 years related experiencein Supplier Quality Management is preferred
• Broad knowledge of manufacturing operations and quality system practices in a Medical Device company is preferred
• Strong knowledge in managing suppliers including supplier evaluation and supplier performance
• Excellent verbal and written communication skills including ability to effectively communicate with internal and external customers
• Organized and detail-oriented with a high level of initiative self-motivation and energy
• Demonstrated experience on the performance of audits lead-auditor certification preferred

Travel Requirements:

• Travel 30-40% of the time including occasional international travel.
• Flexibility and ability to engage in virtual meetings across time zones

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

• Familiar with ISO 9001 Knowledge of ISO13485 FDA QSR or China NMPA will be added advantage
• Familiar with problem solving tools such as 5 why root cause analysis and Quality tools such as DFM PFMEA GR&R Control Plan SPC.

SCIEX a Danaher operating company offers a broad array of comprehensive competitive benefit programs that add value to our lives. Whether its a health care program or paid time off our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info.

Join our winning team today. Together well accelerate the real-life impact of tomorrows science and technology. We partner with customers across the globe to help them solve their most complex challenges architecting solutions that bring the power of science to life.

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