Beckman Coulter is looking for a dynamic individual to lead our quality efforts on new product teams for the development of Immunoassay reagent products. This quality representative will assure product quality excellence from requirements through design transfer. In addition, this individual will facilitate the implementation of Design for Six Sigma concepts in the reagent development and transfer process, along with being an integral part of the reagent process design, characterization and verification/validation activities.

Expertise in the following areas is required for consideration:

• Immunoassay/Molecular In-Vitro Diagnostics or medical device Development and/or Manufacturing experience – required

• FDA/ISO Quality System and Risk Management experience - required

• Chemical process characterization, scale-up and validation experience - preferred

• Design For Six Sigma (DFSS) experience – preferred

• Six Sigma Green or Black Belt Certification - preferred

• Multi-functional project leadership and/or people management experience – preferred

• Degree in Chemical Engineering – preferred

• Advance degree in science or other technical/engineering disciple will be considered

Experience: BS. with 6+, M.S. with 4+ years or a PhD with 2+ years

Demonstrated abilities for consideration:

• Proven track record in Immunoassay, molecular biology or other chemical product development, or production.

• Ability to provide in-depth data analysis to answer complex technical questions

• Experience training and managing technical staff

• Ability to effectively communicate to ensure positive outcomes across a multidisciplinary team

• Skilled in continuous process improvement approaches and implementation

• Ability to successfully implement system/culture changes

• Proven track record of process validation and development approaches

• Ability to transfer products/processes from design to production

• Ability to define and assess objective evidence for FDA and ISO Quality System compliance

• Expertise considered a plus: Assay development, experience in chemical or bio-pharmaceutical protein process engineering, mathematical modeling, and mechanical systems experience.

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.

Please apply online at:  https://recruiter.kenexa.com/bci/cc/CCJobDetailAction.ss?command=CCViewDetail&ccid=bupJEdUjsTs=&job_REQUISITION_NUMBER=60511