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GROUP MANAGER PRODUCT DEVELOPMENT CENTER
Beckman Coulter, Inc. is a leading manufacturer of biomedical testing instrument systems, tests and supplies that simplify and automate laboratory processes. Spanning the biomedical testing continuum- from pioneering medical research and clinical trials to laboratory diagnostics and point-of-care testing- Beckman Coulter's 200,000 installed systems provide essential biomedical information to enhance health care around the world.
Beckman Coulter is in the business of "Innovating Processes for Biomedical analysis." In addition to meeting customer needs with high quality, state-of-the-art instrument systems, the company develops collaborative relationships to help customers to identify ways to maximize the efficiency of those systems in their processes. This is referred to as The Power of Process. Why not consider becoming a part of a company that makes a difference in saving and improving the quality of lives around the world
Directs and controls a Product Development functional unit, often as a lead contributor, in Assay, Chemistry, Software and/or Systems Development; Clinical Affairs; and/or Quality Assurance. The incumbent directs the design, development, verification and validation of design to ensure the timely completion of products at projected costs within specified performance parameters; manages scientific, engineering and/or technical staff; participates in multifunctional project teams; develops and maintains strong collaborative development partnerships with opinion leaders; and ensures all FDA, ISO and related regulatory requirements are consistently met.
•Responsible for the functional management of the Post Commercialization and Applications Development Department, including Budget and Staff
•Leads and Manages the CF/CAPA Process
•Provides direction and collaboration to ensure timely response to CFs and CAPAs to meet Corporate guidelines
•Provides support and oversight on Complaint Investigations, Failure Investigations, and Adverse Event documentation
•Works collaboratively with Line Engineering, Technical Support, and Product Development in Root Cause determination
•Supports and Introduces new tools and processes associated with the Customer Complaint and CAPA Process
•Provides Technical Expertise when reviewing or assisting investigators in the completion of required documentation
•Facilitates team activities and provides active support
•Participates and provides technical assessment on issues discussed during Adverse Events / Product Corrective Action Subcommittee
•Main contact during FDA and Internal Audits performed on the complaint and CAPA system
Preferences:
•Must be familiar with complaint handling processes
•Must be proficient with Microsoft Office tools
•Experience or background with Beckman Coulter instrumentation (Hematology, Cytometry, or Particle Characterization) a plus
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| Additional Information |
Position Type:
Employee
Ref Code: BCI18287F |
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