Danaher Corporation Quality Specialist, Product Quality 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:
Generate COA(Certificate of Analysis)/ COC(Certificate of Compliance/Conformance) for required Consumable & Options for relevant products.
Upload COA/ COC to the relevant repository (eg. Sciex website) for ease of retrieval by customers. Work with related associates to address & resolve any issues encountered during the process when required.
Perform outgoing product release (Device History Records buy-off) and inspection on instruments according to documented procedures.
Work with process owners to resolve non-conformances detected at outgoing product release & inspection.
Generate charts/ trends of outgoing product release & inspection performance.
Analyze quality data, correctly interpret results and make appropriate recommendations where applicable.
Maintain & comply with the requirements of ISO9001, ISO13485, FDA 21 CFR Part 820 and other applicable regulatory requirements.
Work with the Quality Assurance (QA) Manager to develop action plans & reports.
Ensure compliance, within area of concern, to all relevant EHS regulatory requirement and SCIEX safety policies, procedures, and guidelines
Other duties/ ad hoc tasks as assigned.
We are looking for professionals with these required skills to achieve our goals:
NITEC/Diploma in Engineering or related fields
1 year of relevant working experience in manufacturing environment
Knowledge of ISO9001
If you have the following experiences, it would be a plus:
Ability to read technical drawings and experience in writing procedures to QMS requirements
Knowledge of the following QMS standards - ISO9001 QMS, ISO13485 QMS and FDA 21 CFR Part 820 is strongly desired
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.
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.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.