Engineer, Product Quality
2 weeks ago
For over 50 years, SCIEX has been developing groundbreaking technologies and solutions in mass spectrometry and capillary electrophoresis. Our products enable our customers to quickly respond to environmental hazards, better understand biomarkers relevant to disease, improve patient care in the clinic, bring relevant drugs to market faster and keep food healthier and safer. At SCIEX, you’ll find a rewarding role that amplifies your impact on the world and helps you realize life’s potential.
SCIEX 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.
Learn about the Danaher Business System which makes everything possible.
Interested in problem solving using systemic approach? Do you want to be part of team that is responsible for product quality that is used in medical research? Passionate about working with cross functional teams?
The Product Quality Engineer is responsible for ensuring the quality of our product, the mass spectrometer, through the investigation of internal and external quality issues.
This position is part of the Quality Assurance & Regulatory Affairs Team and will be based on-site in Singapore.
**In this role, you will have the opportunity to**:
- Drive closure of NCMRs (Non-Conforming Material Reports) and CAPAs (Corrective and Preventive Actions) related to RTY (Rolled Throughput Yield), CDT&R (Customer Defect Tracking & Resolution) issues and complaints. Participate in the relevant meetings & related activities as required.
- Provide regular progress reports and quality metrics (pareto and trending) to management and cross-functional stakeholders, including developing resolutions as needed to improve metrics achievement (e.g. NCMR, etc.)
- Keep abreast of DBS (Danaher Business System) tools, such as 5S, DMP, PSP, pFMEA, SW, and TPI to drive continuous improvement with sustainable results.
- Participate and support in design transfer activities & NPI project for transition to Singapore Operations, to ensure that all relevant technical procedures and requirements are met before commercial go-live (e.g. complete risk documents, etc.)
- Perform regular audits on production processes and continuously work with cross-functional teams to rectify audit findings to ensure production is audit ready.
**The essential requirements of the job include**:
- Bachelor's degree in a scientific or engineering discipline (mechanical, electrical, software/computer engineering expertise preferable) from four-year college or university and/or training or equivalent combination of education and experience
- Minimum 2 years’ experience of working in a regulated environment (ISO 13485:2016 and ISO 9001:2015)
- Familiarity with implementation of ISO 14971, IEC 62304, 21 CFR Part 820 and 21 CFR Part 11
- Hands-on experience in Risk Management as it relates to medical device products and processes.
**It would be a plus if you also possess previous experience in**:
- Implementing ISO 13485, ISO 14971, and FDA regulations for new and sustaining products.
- Developing PFMEA and PCP for new and sustaining products.
- MS Excel (advanced level) and statistical process control
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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