Job Description

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 Design Transfer activities for the project transition to Singapore Operations. Includes ensuring all relevant technical procedures and requirements are met before commercial go-live.
Provide data analysis & trending of processes & products characteristics and other feedback or escalate on current issues to the supporting functions on a regular basis.
Perform Statistical Process Analysis (SPC) or equivalent on product and process performance to improve product quality.
Manage and drive the relevant supporting functions on corrective/preventive action activities related to product in-process quality, post-market surveillance activities, etc.
Drive closure of NCMRs and CAPAs related to RTY (Rolled Throughput Yield), CDT&R(Customer Defect Tracking & Resolution) issues and complaints. Participate in the relevant meetings, discussions, improvement activities as required.
Assist in the investigation & analysis and to follow-up with the cross-functional team to ensure root causes are addressed & gap closed, improvement actions are implemented in a timely manner.
Apply the applicable quality tools and statistical methods for improvements or preventions of possible failures, and influencing the others adopt and applies the same or similar statistical methodologies.
Support Product final release to meet output demand that achieving business revenue.
Ensure that all product changes are captured by valid ECOs and respective procedures to be reviewed and updated to reflect the true status of the practices.
Participate and support in continuous improvement activities in a cross-functional environment, (e.g. Kaizen).
Part of the Internal Audit team, to conduct respective production Line qualification readiness audit, Gemba audit, and/or process audit, to ensure gaps are captured and escalate for improvements.
Mentor and coach others as and when is needed.
Maintain and comply with the requirements of ISO9001, ISO13485, FDA 21 CFR Part 820 and other applicable regulatory requirements.
Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
Bachelor degree in Engineering or equivalent.
A minimum of 2 years of related experience in a manufacturing environment especially instruments manufacturing.
Good understanding of the following QMS standards - ISO9001 QMS, ISO13485 QMS and FDA 21 CFR Part 820 is strongly desirable.
Ability to read technical drawings and experience in writing procedures to QMS requirements.
Knowledge of MS Office (Word, Excel) and other quality tools (Minitab, FMEA, SPC, DOE, etc.) and their application.
Certification in SPC/Six Sigma green/ black belt is an advantage.
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.
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.