Job Summary
- Company
- Beckman Coulter, Inc.
- Location
- Brea, CA 92821
- Industries
- Biotechnology/Pharmaceuticals
- Job Type
- Full Time
- Employee
- Career Level
- Experienced (Non-Manager)
- Job Reference Code
- BCI64353M
SENIOR QUALITY AND REGULATORY AFFAIRS SPECIALIST
About the Job
Beckman Coulter develops, manufactures and markets products that simplify, automate and innovate complex biomedical testing. Our diagnostic systems are found in hospitals and other critical care settings around the world and produce information used by physicians to diagnose disease, make treatment decisions and monitor patients. Instruments for life science research are used by scientists as they study complex biological problems including the causes of disease, identify new therapies, and test new drugs. Our customers include hospitals, physicians' offices, diagnostic reference laboratories, pharmaceutical and biotechnology companies, universities, medical schools and research institutions. In fact, Beckman Coulter has more than 200,000 clinical and research instrument systems operating in laboratories around the world.
From complex DNA sequencing to simple diagnostic screening kits, Beckman Coulter is one of the world’s largest companies devoted solely to biomedical testing. The company, based in Fullerton, California has operations in more than 130 countries, we employ over 11,000 employees including research scientists, engineers, manufacturing associates and other professional and technical staffs. We offer opportunities for every employee to make an impact at Beckman Coulter—and on the health of people worldwide through our products which support advances in patient care.
Job Description:
Must also have the following demonstrated knowledge, skills, and abilities:
From complex DNA sequencing to simple diagnostic screening kits, Beckman Coulter is one of the world’s largest companies devoted solely to biomedical testing. The company, based in Fullerton, California has operations in more than 130 countries, we employ over 11,000 employees including research scientists, engineers, manufacturing associates and other professional and technical staffs. We offer opportunities for every employee to make an impact at Beckman Coulter—and on the health of people worldwide through our products which support advances in patient care.
Job Description:
- Responsible for the creation and implementation of corporate documents to support the organization wide 1QMS initiative.
- Coordinate the continued development and implementation of the Quality System, including the policies and procedures to meet necessary requirements of the Quality System specifically to US FDA’s 21 CFR, ISO 9001:2008, ISO 13485:2003, European Union MDD 93/42/EEC, IVDD 98/79/EC, Health Canada’s CMDR, J-PAL and other international requirements as they become applicable.
- Formulates and monitors project plans and recommends process improvements.
- Participate in Regulatory strategies and compliance activities
Must also have the following demonstrated knowledge, skills, and abilities:
- Bachelor’s degree in Science or in a related field (MS degree preferred).
- Minimum of 5-7 years of experience in Quality & Regulatory in medical device industry.
- Must have demonstrated working knowledge of domestic and international quality standards in a government regulated healthcare industry.
- Must have effective leadership, problem solving, negotiation skills, and diplomacy in dealing with team members, as well as the ability to assess the impact of regulatory and quality compliance methods.
- Advanced computer skills in MS word, excel, access, power point and knowledge of Adobe Captivate software.
We are Better Together
We are Better Together: collaboration across all business centers and functions-fundamental to our success. You will join an established, profitable and highly successful global leader that has proven itself capable of evolving to meet the needs of the marketplace and maintaining a healthy growth rate throughout.
Career Development:advancement opportunities and diverse career paths are trademarks of the Beckman Coulter experience, and as you master your accountabilities, you will be ideally positioned to evolve along multiple career paths.
Excellent benefits:in addition to a very competitive salary and bonus opportunity, we offer a robust benefits package that includes low cost health insurance coverage for you and your family; matching 401(k) as well as a retirement account plan; stock purchase options; paid time off (PTO) and holidays.
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 at www.beckmancoulter.com.
Apply Online : https://recruiter.kenexa.com/bci/cc/CCJobDetailAction.ss?command=CCViewDetail&ccid=bupJEdUjsTs=&job_REQUISITION_NUMBER=64353
Company Tools
Contact Information
Beckman Coulter, Inc.
