Senior Quality Engineer, PQE

3 weeks ago

Singapore Danaher Corporation Full time

Leica Microsystems has helped shape the future of microscopy for over 170 years 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 proud to work alongside a community of nine fellow Danaher Life Sciences companies. Together, we're pioneering the future of science and medicine, developing products that enable researchers in the fight to save lives.

Senior Quality Engineer, PQE

OverviewProvide Quality Engineering support for Manufacturing Operations and resolving Quality issues with Process Engineers using standardized investigation tools. Drive changes, improvements and implementing quality control strategies.

Responsibilities

  • Investigate manufacturing product quality and compliance issues (e.g. non-conformances, audit observations, customer complaints) for production processes based on engineering principles and problem-solving methodologies. Quality Control plan, NCMR and sign off.
  • Partner with engineering team (cross functional teams) on root cause investigations and/or corrective actions, perform non-conformance investigations for review with engineering, assures documentation content is valid, provide regular progress reports and quality metrics to management and cross-functional stakeholders, including developing resolutions as needed to improve metrics achievement.
  • Review and analyse key Quality Indicators and collaborate with manufacturing department to proactively resolve non-conformances and operational issues. (Pareto), trending, KPI (PDOA, Ext PPM)
  • Supervise employees and quality activities pertaining to the production of products and/or manufacturing processes in - and with quality /technical knowledge of - multiple production areas, depending on the complexity of the areas, in addition to conducting performance reviews, including resolving performance issues.
  • Drive Quality and Productivity improvement by participating in lean and continuous improvement initiatives and projects. DHR/DMR , change control eg process and production line changes, outgoing inspection, review gaps and outgoing inspection effectiveness.
  • External comm to customer, prepare/sign product certs
  • Review, update and maintain risk management files. (review)
  • Keep abreast of DBS tools, such as 5S, DMP, 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.

Requirements

  • Degree in Mechatronics/Mechanical Engineering/Electronics.
  • Minimum 5 years relevant working experience in an assembly operations/engineering environment.
  • Good knowledge of various statistical control method and strong background in QMS 9001. Familiar with ISO13485, USFDA QSR/cGMP (21 CFR Part 820) and ISO14971 for medical devices is a plus.
  • Computer literacy in MS Office modules and Lotus Notes.
  • Strong analytical and problem-solving skills.
  • Knowlegeable in lean and investigation tools such as 8D and fishbone diagram.
  • Substantial understanding and knowledge of principles, theories and concepts relevant to Engineering.

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

Learn more about what we do and who we are by watching our company video "We Are Leica":

Are you interested to discover new opportunities in an innovative, team-oriented environment? Do apply online with your complete documents (cover letter, CV, certificates). We are looking forward to your application

When you join us, you'll also be joining Danaher's global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you'll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System tools and the stability of a tested organization.

Danaher is committed to a diverse and inclusive culture where everyone feels they belong and all voices are heard. We believe in our associates and the unique perspectives they bring to every challenge, which is why we'll empower you to push the boundaries of what's possible.

If you've ever wondered what's within you, there's no better time to find out.

At Danaher we bring together science, technology and operational capabilities to accelerate the real-life impact of tomorrow's 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. Our global teams are pioneering what's next across Life Sciences, Diagnostics, Biotechnology and beyond. For more information, visit

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.


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