- Define, and apply the manufacturing quality toolset including NCR, SCAR, MRB, DPFMEA, IQ, OQ, PQ, GR&R/measurement system analysis, control plans, process verification/validation plans, validation protocol development, Cpk/PpK, SPC, incoming inspection plans, inspection methods, DOE, process data analysis, and DMAIC/Problem Solving
- Establish needed quality proactive initiatives including supplier audits, supplier process assessments, change notifications, supplier corrective action processes, supplier qualifications, and supplier evaluations
- Represent and lead Quality in VAVE/engineering projects providing quality engineering services to assigned projects
- Ensure defendable engineering and scientific analyses are employed and design history files comply with company policies and governmental regulations
- Bachelor's degree in Engineering, BioMedical, Bioengineering, Chemistry, or related discipline and with a minimum 5 years of related experience in SQE/QE.
- Certified Lead Auditor.
- Develop and understand the application of production and process controls including process validation, process control plans, and statistical process control utilizing best practices and innovation.
- Experience and mastered the utilization and application of Statistical methods for computing and analyzing data, and driving measures and actions for improvement.
- FDA / GMP 21CFR820 / ISO 13485
- Electro-Mechanical Contract Manufacturing and Injection Molding
- Certified Quality Engineer
Senior Supplier Quality Engineer - Penang, Malaysia - Cepheid
Description
At Cepheid, we are passionate about improving health care through fast, accurate diagnostic testing. Our mission drives us, every moment of every day, as we develop scalable, groundbreaking solutions to solve the world's most complex health challenges. Our associates are involved in every stage of molecular diagnostics, from ideation to development and delivery of testing advancements that improve patient outcomes across a range of settings. As a member of our team, you can make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development.
Cepheid is proud to work alongside a community of six fellow Danaher Diagnostics companies. Together, we're working at the pace of change on diagnostic tools that address the world's biggest health challenges, driven by knowing that behind every test there is a patient waiting. Learn about the Danaher Business System which makes everything possible.
The Senior Supplier Quality Engineer is responsible for quality engineering and management activities with suppliers driving quality improvement, ensuring compliance, and supporting Value Add Value Engineering (VAVE) / localization project activities. Working in conjunction with the Supplier Quality Engineering team in Sunnyvale, California, USA, you will also assist in partnering with suppliers to drive proactive and systematic improvements and working closely with Instrument Contract Manufacturers in the region.
This position is part of the Supplier Quality Engineering and will be located in Penang, Malaysia - Remote.Our vision is to be the leading provider of seamlessly connected diagnostic solutions.
In this role, you will have the opportunity to:
The essential requirements of the job include:
It would be a plus if you also possess previous experience in the following:
At Cepheid we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, remote working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a remote work arrangement in which you can work remotely from your home. Additional information about this remote work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Cepheid can provide.
When you join us, you'll also be joining Danaher's global organization, where 80,000 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.
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.
If you've ever wondered what's within you, there's no better time to find out.