- Entry level
- No Education
- Salary to negotiate
Danaher Company Description
Beckman Coulter develops, manufactures and markets products that simplify, automate and innovate complex biomedical testing. Our diagnostic systems, found in hospitals and other critical care settings around the world, produce information used by physicians to diagnose disease, make treatment decisions and monitor patients. Scientists use our life science research instruments to study complex biological problems including causes of disease and potential new therapies or drugs. More than 275,000 Beckman Coulter systems operate in both diagnostics and life sciences laboratories on all seven continents. For 80 years, our products have been making a difference in peoples’ lives by improving the productivity of medical professionals and scientists, supplying critical information for improving patient health and reducing the cost of care.
Beckman Coulter offers a broad array of comprehensive, competitive benefit programs that add value to associates' and their families' lives. Whether it's a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits. We think you'll like what you see.
If you believe your education and experience are in line with the position description and qualifications referred to above, and are motivated, energetic, and looking for a new and exciting opportunity, please submit your resume online at the URL below or atwww.beckmancoulter.com.
Beckman Coulter is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, national origin, religion, gender, age, marital status, disability, veteran status, sexual orientation, gender identity, or any other characteristic protected by law.
An incumbent at this level ordinarily performs the full range of quality control inspection duties and computer system transactions. The incumbent will have been qualified by specialty training or experience performing quality control tasks requiring knowledge of Manufacturing/Q.A. systems and demonstrate capability to apply expertise. Ensure proper adherence to manufacturing documentation and processes. Approximately 75% of time will be spent on routine QCI assignments such as batch record review and 25% on quality system projects including document revision, reports and other quality improvements.
* Batch record review and finished goods release while ensuring that product specifications and company and regulatory requirements are met.
* Inspection and disposition of incoming parts following approved specifications and procedures.
* Reviews and updates Standard Operating Procedures as needed.
* Creates Real Time Stability final reports using Minitab for data analysis. Also conducts final review of reports as needed.
* Reviews and approves change orders as needed to support the business needs.
* Collaborates with other local functional groups including Manufacturing, Quality Assurance, Quality Control Test and Warehouse/Inventory Control.
* Ensures company, industry, and regulatory standards are met, e.g. ISO 13485, 21 CFR 820, MDSAP, IVDR, Quality Policies and SOPs of Beckman Coulter.
* Serves as QCI team member on multi-department diagnostic projects for process improvement and new products as required.
* Other duties may include training and implementing quality improvements through leading kaizens and/or dives.
* Potential for growth into a lead or higher level in quality.
Education and Experience:
* * High school degree (or equivalent degree) with 7 years of experience
* Two or more years of quality control or quality assurance work experience at a medical device (FDA/GMP) manufacturer or equivalent applicable work experience preferred.
* Experience with collaborative cross-functional teams desired
* Experience with Lean tools or other continuous improvement tools desired
* * Good understanding of ISO 13485, MDSAP, IVDR and FDA GMP regulations for Medical Diagnostics industry.
* Good understanding of good documentation practices.
* Good written and verbal communication skills, including ability to write and edit procedures and reports
* Good attention to detail.
* Familiarity with QC lab testing is preferred.
* Strong problem solving and conflict resolution skills.
* Demonstrates behavior, judgment, discretion and performance consistent with the quality policy and goals of Beckman Coulter.
General Physical Requirements (As required by the Americans With Disabilities Act):
* * Requires lifting 15 pounds and sitting/standing for extended periods of time.
* The location are areas such as office, labs, warehouse, cold boxes; computer terminals for inquires and transactions; space for adequate separation, identity, and storage of materials in inspection status; quarantine areas for defined subgroups of materials. Gowning is required in production environments and QC lab.
*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.
Organization: Beckman Coulter - Diagnostics
Job Function: Quality and Regulatory Affairs
Primary Location: North America-North America-United States-CA-Carlsbad
Req ID: BEC016352
- quality control
About the company
Danaher is a global science and technology innovator committed to helping our customers solve complex challenges and improve quality of life around the world. A global network of more than 20 operating companies, we drive meaningful innovation in some of today’s most dynamic industries through our operating companies in five strategic platforms: Life Sciences, Diagnostics, Dental, Water Quality and Product Identification. The engine at the heart of our success is the Danaher Business System (DBS), a set of tools that enables continuous improvement around lean, growth and leadership. Through the ingenuity of our people, the power of DBS and the impact of our meaningful technologies, we help realize life’s potential in ourselves and for those we serve.