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Principal Quality Engineer, Production Quality

3 weeks ago

Downtown Core, Singapore Leica Microsystems Full time

For over 170 years, Leica Microsystems has helped shape the future by developing groundbreaking optical and digital solutions. As a global leader, we’re driven by continuous improvement to excite our customers and to create the best work environment for our people. Customer focus, innovation, and teamwork are at the core of our culture and the foundation of our success.

Want to be part of a company whose products are part of cutting-edge research around the world? Join Leica Microsystems in our commitment for brilliant solutions and insight.

Leica Microsystems is one of 10 Life Sciences companies of Danaher. Together, we accelerate the discovery, development and delivery of solutions that safeguard and improve human health.

We currently offer the following position in our office in 15 Tukang Innovation Drive, Singapore 618299 which will be onsite workplace model.

**WHAT YOU WILL DO**
- Lead in investigating manufacturing product quality and compliance issues such as non-conformances, audit observations, customer complaints for production processes based on engineering and statistical principles and problem-solving methodologies.
- Be a Member of Material Review Board. Review, evaluate and determine the disposition of non-conforming material
- Partner with engineering and supplier quality teams (cross functional teams) on root cause investigations on customer complaints and assures documentation content is valid.
- Lead PDOA investigation and drive quality improvement
- Lead, review and analyse key Quality Indicators and collaborate with manufacturing and supplier quality departments to proactively resolve non-conformances and operational issues.
- Perform data analysis (pareto and trending) for compliant (PDOA and External PPM) and non-conformances to identify systemic improvements.
- Provide regular progress reports and quality metrics to management and cross-functional stakeholders, including developing resolutions as needed to improve metrics achievement.
- Supervise employees and quality activities, including MD and ID, pertaining to the production of products and/or manufacturing processes in - and with quality/statistical/technical knowledge of - multiple production areas, including calibration, in addition to conducting performance reviews, including resolving performance issues.
- Drive and influence Quality and Productivity improvement by participating in lean and continuous improvement initiatives and projects.
- External communication to customer, prepare/sign product certs
- Review risk management files and validation document.
- Keep abreast of DBS tools, such as 5S, DMP, PSP, pFMEA, SW, and TPI to drive continuous improvement with sustainable results.
- Ensure the department operates under the Quality Management System and Environment, Health & Safety (EHS) requirements and to address EHS issues raised by associates.

**OUR EXPECTATIONS**
- Degree in Mechatronics/Mechanical Engineering/Electronics with minimum 8 years relevant working experience in an assembly operations/engineering environment.
- Good knowledge of PFMEA, process/software validation and various statistical control method.
- Strong background in QMS 9001. Familiar with ISO13485, Medical Device Regulation, USFDA QSR/cGMP (21 CFR Part 820) and ISO14971 for medical devices is a plus.
- Strong analytical and problem-solving skills.
- Knowledgeable root cause investigation tools such as 5 Whys, fish bone diagram and Is/Is Not analysis.
- Substantial understanding and knowledge of calibration, measurement techniques and metrological concepts is preferred.
- Computer literacy in MS Office modules and Lotus Notes is advantageous.

**WHAT WE OFFER**
- Equal pay is a given for us.
- Learn all there is about Kaizen, PSP's and Muda as part of our Danaher Business System (DBS) trainings - if you believe in continuous improvement like us
- We have no room for prejudices and stereotypes. We promote equal opportunities, diversity and inclusion.
- We offer a balance between support and autonomy to achieve your own goals in an international environment

**GET MORE INSIGHT**

At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.