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:
The successful candidate for this role will have strong technical experience of product quality in electromechanical and/or software integrated systems, preferably with hands-on experience for Process or System Verification and Validation activities in NPI process.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:
Work closely with DQE and manufacturing engineering to ensure timely development and deployment of new product transfer protocols and qualification activities in releasing for production.
Lead NPI transfer activities as Quality representative in collaboration with cross-functional stakeholders including R&D, PMO, Supplier Quality, Global Sourcing/Procurement, Planning, DQE, Manufacturing Production and Engineering.
Work closely with Manufacturing Production and Engineering to ensure the applicable risk management documents are established and approved prior to release for mass production, such as PFMEA, Control Plan, Work Instruction, etc.
Review manufacturing procedures for transfer project that ensure conformance to QMS requirement and align with actual practices to the site, such as Work Instruction, Product release checklist, etc.
Ensure Device Master Record index (DMR) comply with company procedures and regulatory requirements and make sure its auditable, traceable, concisely organized, complete, and supports regulatory product registration needs.
Ensure adherence to procedures as required by QMS on software, hardware throughout the life-cycle of projects.
Analyze, develop, and recommend quality engineering approaches required to meet design and production requirements. Compile and evaluate production data (i.e. First Pass Yield), identify key product, process, or material factors that escalate for improvement that in consideration of the needs for review and update pFMEA and Control Plan where applicable.
Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues such as work closely with cross-functional stakeholders to ensure NCMR is investigated, dispositioned, and approved appropriately prior to closure. Ensure the NCRM trending is analyzed and reported, makes recommendations, and drives improvements.
Develop Quality Plans where applicable, participate in internal audits and support external audits
Perform review and approval of Engineering Change related activities (i.e. ECR, ECO) ensure the on time implementation of the changes.
Perform review and approval of Deviation related activities ensure conformance to QMS requirements and/or applicable regulatory requirements.
Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
Bachelor's degree in a scientific or engineering discipline (mechanical, electrical, software/computer engineering expertise preferable)
Min. 3-5 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
Preferred Qualifications:If you have the following experiences, it would be a plus:
Hands-on experience in Risk Management as it relates to Medical Devices products and processes
Exposure to and/or experience with verification and validation of Medical Devices in New Product Introductions.
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.