Sr. Manager, Quality Assurance and Quality Control (Medical Device) - Danaher Corporation
Carlsbad, CA 92008
About the Job
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.This position is part of the Quality Assurance & Regulatory Affairs (QARA) team and will be located ON-SITE in Carlsbad, CA, USA.In this role, you will have the opportunity to:Develop strategy and set annual targets for quality and production KPI and process improvements including executing a multi-year roadmap for people and equipment capacity that meets production demand.Utilize Danaher Business System (DBS) tools to drive compliant and effective processes which align with corporate and business unit goals.Work cross-functionally with Operations, R&D, Supplier Quality, Product Management and others to drive continuous product quality improvements. Ensure all activities conducted at the site are compliant with Design Controls and the relevant elements of the Quality System Regulations and ISO requirements.Lead the Quality Assurance and Quality Control teams ensuring associates set annual performance and development goals. Maintain and execute the site-specific Quality Management System in compliance with the SCIEX global QMS, ISO 13485, ISO 9001, and FDA 21 CFR Part 820.Direct the activities of the Quality Engineering team including design transfer of new products and sustaining project support.The essential requirements of the job include: Bachelor’s degree in scientific or technical discipline, preference for degree in Chemistry.Prefer minimum of 5 years of quality assurance experience in a production environment in the Medical Device, Pharmaceutical or Life Science industry.Prefer minimum of 5 years of supervisory experience.Working knowledge of statistics, design of experiments, and risk analysis.Certified Quality Engineer (CQE) and/or internal auditor experience preferred
Travel & Physical/Environment Requirements:Ability for minimal travel required at 10% or less.Ability to navigate a manufacturing environment including use of PPE when required.It would be a plus if you also possess previous experience in:Project management and prioritization of competing initiatives.Product development and design from ideation to launch.Communicating and presenting (verbally and in writing) to all levels within an organization.SCIEX, a Danaher company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives
Whether it’s a health care program or paid time off, our programs contribute to life beyond the job
Check out our benefits at danaherbenefitsinfo.com.The salary range for this role is $145,000 to $155,000 USD
This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting
We may ultimately pay more or less than the posted range
This range may be modified in the future.This job is also eligible for bonus/incentive pay.We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable
The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law.#LI-ND19#thisisbelonging #thebestteamisdiverseAt Danaher we bring together science, technology and operational capabilities to accelerate the real-life impact of tomorrow’s science and technology
We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life
Our global teams are pioneering what’s next across Life Sciences, Diagnostics, Biotechnology and beyond
For more information, visit .Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law
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.The EEO posters are available here.We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment
Please contact us at
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.This position is part of the Quality Assurance & Regulatory Affairs (QARA) team and will be located ON-SITE in Carlsbad, CA, USA.In this role, you will have the opportunity to:Develop strategy and set annual targets for quality and production KPI and process improvements including executing a multi-year roadmap for people and equipment capacity that meets production demand.Utilize Danaher Business System (DBS) tools to drive compliant and effective processes which align with corporate and business unit goals.Work cross-functionally with Operations, R&D, Supplier Quality, Product Management and others to drive continuous product quality improvements. Ensure all activities conducted at the site are compliant with Design Controls and the relevant elements of the Quality System Regulations and ISO requirements.Lead the Quality Assurance and Quality Control teams ensuring associates set annual performance and development goals. Maintain and execute the site-specific Quality Management System in compliance with the SCIEX global QMS, ISO 13485, ISO 9001, and FDA 21 CFR Part 820.Direct the activities of the Quality Engineering team including design transfer of new products and sustaining project support.The essential requirements of the job include: Bachelor’s degree in scientific or technical discipline, preference for degree in Chemistry.Prefer minimum of 5 years of quality assurance experience in a production environment in the Medical Device, Pharmaceutical or Life Science industry.Prefer minimum of 5 years of supervisory experience.Working knowledge of statistics, design of experiments, and risk analysis.Certified Quality Engineer (CQE) and/or internal auditor experience preferred
Travel & Physical/Environment Requirements:Ability for minimal travel required at 10% or less.Ability to navigate a manufacturing environment including use of PPE when required.It would be a plus if you also possess previous experience in:Project management and prioritization of competing initiatives.Product development and design from ideation to launch.Communicating and presenting (verbally and in writing) to all levels within an organization.SCIEX, a Danaher company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives
Whether it’s a health care program or paid time off, our programs contribute to life beyond the job
Check out our benefits at danaherbenefitsinfo.com.The salary range for this role is $145,000 to $155,000 USD
This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting
We may ultimately pay more or less than the posted range
This range may be modified in the future.This job is also eligible for bonus/incentive pay.We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable
The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law.#LI-ND19#thisisbelonging #thebestteamisdiverseAt Danaher we bring together science, technology and operational capabilities to accelerate the real-life impact of tomorrow’s science and technology
We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life
Our global teams are pioneering what’s next across Life Sciences, Diagnostics, Biotechnology and beyond
For more information, visit .Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law
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.The EEO posters are available here.We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment
Please contact us at
applyassistance@danaher.com
to request accommodation.Job SummaryJob number: R1272367Date posted : 2024-08-14Profession: Quality & Regulatory AffairsEmployment type: Full time
Source : Danaher Corporation