Danaher Corporation Engineer, Quality Assurance in Woodlands, Singapore
As a global leader in mass spectrometry, SCIEX delivers solutions for precision detection and quantification of molecules to help protect and advance the wellness and safety of all. Because of our 50 years of groundbreaking innovation, our customers can 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 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.
Purpose of this role:
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:
Support in the internal compliance gap assessment and external audit such as FDA, ISO13485, CGMP, ISO9001, ensure no major finding in Singapore for Quality inspection processes, e.g. First Article inspection, etc.
Plan, organize and ensure In-coming inspection activities performed efficiently and effectively, proper time management and task prioritization.
Perform hands on inspection tasks and conduct comprehensive review of the relevant documents, drawings, specifications, BOM, etc. to ensure its met the inspection passing criteria.
Communicate and work closely with internal cross-functional team in regards aligning the inspection requirements and acceptance criteria, such as Engineering, Design Authority, Global Sourcing, etc.
Able to use measuring instrument, like caliper, micrometer, and high gauge, Smart scope, etc.
Liaise with suppliers for correct submission of the documents and parts per drawings, procedures and to work with them improving their process and resolve part quality issue.
Be the Subject Expect in Incoming Quality Inspection, including required inspection buy off at supplier premises as and when if needed.
Monitor and track inspection task completion through conducting regular DM and necessary discussion with cross-functional to ensure the on-time completion or set the priorities.
Apply quality tools for necessary problem solving and statistical analysis on quality data monitoring and KPI reporting, where applicable (e.g. 5why, 8D report, fishbone diagram, etc).
Adhere to NCMR process while defect or nonconformity is detected, proactively follow up and seek advice from SMEs and ensure appropriate documentation is evident prior to closure, escalate the issues as and when is needed (e.g. critical parts /high risk defect found/affecting production revenue, etc).
Heavily involved but not limited to the New part buy-off in NPI project (e.g. turn on ASL) upon the new part completed and accepted.
Review and align First Article and routine Incoming Inspection process to ensure standardization and best practices across the sites.
Review and update Quality Inspection procedures, ensure the actual practices are aligned and updated for continual improvements.
Conduct necessary training to job requestors and QA technicians or suppliers where applicable, e.g. Procedure, PQP requirements, etc.
We are looking for professionals with these required skills to achieve our goals:
Diploma or Bachelor’s degree in engineering or equivalent.
Min 3 year experience in an instrument / equipment manufacturing environment in a quality function.
Good understanding of the following QMS standards - ISO9001 QMS, ISO13485 QMS and FDA 21 CFR Part 820
Experience in handling or managing Oracle or Enovia or equivalent systems.
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 (https://www.danaher.com/how-we-work/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.
Moderate to Excellent writing and oral communication skills with the ability to effectively interface with a variety of associates at various levels.
Detail oriented with Good organizational and time management skills.
Able to work independently.
Knowledge of MS Office (Word, Excel) and other quality tools (5Why, Fishbone diagram, 8D report, SPC) and their application and basis data analysis skills.
Experience in an instrument / equipment manufacturing environment in a quality function is a plus.
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 (https://www.danaher.com/how-we-work/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.