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.

The Quality Assurance Engineer plans, coordinates, and reports on product quality for manufactured and supplied plastic parts. The incumbent provides data for technical decisions using techniques in experiment design and data analysis and resolves issues of discrepancy in experiment design and data. The incumbent also represents QA on various teams (development, current business, product improvement), assures the accuracy of product labeling and compliance, coordinates complaint management activities and Customer Feedback failure investigations, reviews, implements and revises product, project and program quality activities. Other responsibilities include: providing design review and risk assessment expertise, recommending appropriate field actions to product regulatory committees, adherence to technical standards, policies and procedures, developing and tracking project plans, recommending process improvements, and providing quality training for QA and manufacturing personnel.


QUALIFICATIONS
• Bachelor’s degree in engineering or science
• 3+ years of experience in a regulated (FDA, ISO, or GMP) environment
• 3+ years of quality experience in a plastic injection molding manufacturing setting
• Proven experience with various quality tools: DFM, DFMEA, PFMEA, DOE, DMAIC, Six Sigma, Process Validation, etc.
• Effective teamwork, interpersonal, and leadership skills
• Excellent reporting and presentation skills


PREFERRED QUALIFICATIONS
• Certified Quality Engineer
• Certified ISO Lead Auditor
• Six Sigma Black Belt

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 .

AN EQUAL OPPORTUNITY EMPLOYER - We believe that the mutual goals of our business and the community can best be met through our policy that consideration of race, color, religion, ancestry, national origin, sex, age, disability, veteran status or other protected characteristics, has no place in the selection, training or promotion of employees. In furtherance of this policy, we have developed a written Affirmative Action program to ensure positive action in providing equal opportunity for employees and applicants.

Apply online at: https://recruiter.kenexa.com/bci/cc/CCJobDetailAction.ss?command=CCViewDetail&ccid=bupJEdUjsTs%3D&job_REQUISITION_NUMBER=66834