At Radiometer, our mission is to help caregivers make diagnostic decisions that save lives. To provide caregivers the insight and confidence that help them arrive at the right diagnostic decisions – decisions that in the end help save lives.
On a yearly basis millions of lives are touched by the information our solutions provide and that’s a fact, we take very seriously; the more critical the setting, the greater the requirements are and that’s why we’ve made it our vision to improve global healthcare with reliable, fast and easy patient diagnoses.
Want to know more about our mission and vision? Click on the link: Link of YouTube video
At Radiometer, we acknowledge that the information our products provide is often the difference between life and death; an acknowledgement that drives and unites us as a company. From biotech and software specialists to financial controllers and engineers, all 3800 colleagues are committed and dedicated to help realize life’s potential.
If you aspire to be part of a purpose, performance and values driven organization whose mission and vision guide every action, we are eager to hear from you.
The primary responsibility of this position is to define and implement quality assurance and quality control processes in support of the quality goals of SenDx Medical, Inc. This position actively participates in product development team activities to ensure that the manufacturing processes conform to FDA and ISO standards. The incumbent will serve as a technical resource to product development, manufacturing and suppliers to improve process capability, reliability and the quality of products. Will create quality and process improvement plans and determine root cause analysis.
PRINCIPAL ACCOUNTABILITIES/ESSENTIAL JOB FUNCTIONS
Continuously improve and develop processes for CAPA, NCR ensuring the processes and contents are in compliance with both relevant regulatory and internal requirements.
Responsible for internal audit programs and for establishing problem solving activities to find root causes and implement effective countermeasures.
Responsible for quality data analysis, trending, root cause investigation and driving to implementation of countermeasures.
Responsible for presenting quality data analysis to support daily management and management reporting.
Drive quality related improvement projects through cross functional teamwork.
Knowledge about verification and validation of products and processes.
Support manufacturing value streams in quality related matters when needed.
Be up-to-date with standards, regulatory requirements and directives applicable for SenDx products.
Ensure the QA system is kept lean and updated and that the organization complies to the system.
Work with Radiometer Medical to develop and implement global procedures.
Utilize Danaher Business System (DBS) concepts and tools in the performance of daily activities.
Perform other duties & projects as assigned.
Education: Bachelor’s degree in Engineering or Sciences required
Experience: 0-3 years of experience in a regulated industry
Skill/Aptitude: Experience in a FDA regulated industry or ISO certified organization is preferred. Strong in statistical data analysis.
Alternate Qualifications: ASQ Certification desirable
Required Licenses: None
Reports To: Director, Regulatory Affairs & Quality Systems
Supervisory Responsibilities: None, may be required to supervise technician or inspector on a project basis.
Key Internal Customers: Daily interface with Research and Development, Engineering, Quality Assurance, Regulatory Affairs, Manufacturing, Manufacturing Engineering, Technical Service on project and product issues.
Key External Customers: Occasional interfacing with customers for purposes of resolving product problems.
Diversity & Inclusion
At Danaher, we are dedicated to building and sustaining a truly diverse and inclusive culture. These are not just words on a page—Diversity and Inclusion is a top priority for the company, and it ties deeply to each of our core values. Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.
Danaher Corporation Overview
Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, environmental and applied solutions. Our globally diverse team of 71,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $19.9B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 5,200% over 25 years.
At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We're innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you'll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.
Danaher is committed to competitive compensation that typically has key components including base salary, variable annual incentive compensation based on personal and company performance, and long-term incentive.
Job Function: Quality and Regulatory Affairs
Primary Location: North America-North America-United States-CA-Carlsbad