美国Beckman Coulter Inc高级质量评估员岗位

Senior Quality Systems Assessment Specialist - 55531 : Miami, FL 33196

Position

a postdoctoral position—senior quality systems assessment specialist

Institution

Beckman Coulter Inc.

Website

http://www.beckmancoulter.com

Location

Miami, FL 33196

Date Posted

May 01, 2009

Date Expires

June 30, 2009

Description

The Senior Quality Systems Assessment Specialist assures integration of key quality strategies in the company or business unit, which enhance integrity of products or processes to meet internal/ external requirements. Partner with internal departments on quality processes including, product development, product transfer, manufacturing operations and post market systems to assess and provide expert guidance on industry best practice through implementation of process improvements. Perform system assessments to ensure compliance quality policies, procedures, regulations and standards, including conducting investigation and root cause analysis for preparing responses to internal and external audits. Perform trending and data analysis for product issues and process metrics.

Job Responsibilities:
1.Quality System support and guidance for, development, technology transfer, manufacturing, including process validation and post market product support of Beckman Coulter Systems.
2.Assessment of quality processes as CPI and implementation of process changes through change management and procedural development.
3.Preparation of Quality System Management Review.
4.Application of Risk Management throughout the quality system in accordance with ISO 14971.
5.Provide the forum and clearly communicate risks to Management and prioritize based upon risk and business impact.
Investigation and root cause analysis using Six-Sigma Methods and decision focus tools.
6.Metrics (analysis of data to identify existing and potential causes of non-conforming product or other quality issues using appropriate statistical and non-statistical methodologies, including routine review of Quality Indicators for trends, adjust priorities accordingly.
7.Plan, schedule and perform internal, supplier and OEM audits, including generation of audit reports and corrective action management.
- Assist in Notified Body and Regulatory Agency assessment/inspections and responses

Requirements:
1.Bachelors degree in life science or engineering field
2.Minimum 5 years relevant work experience
3.Certified lead auditor ISO:13485
4.Comprehensive understanding, interpretation and application of ISO 13485:2003, ISO 9001:2008, 21 CFR 820, and solid knowledge of IVDD, CMDR and JPAL.
5.Proficient with data analysis and data mining using software application such as Business Objects or Siebel.
6.Proven experience with failure investigations and root cause analysis, and CAPA Systems
7.Demonstrated experience with product development and post market risk management
8.Excellent verbal and written communication skills
9.Basic quality engineering skills
10.Solid understanding of Instrument and Reagent development, and manufacturing with a system level understanding for product support.
- Ability to work with a sense of urgency and focus in fast paced, multi-task environment

Contact

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.

来源：http://www.nature.com/naturejobs/science/jobs/95547-Senior-Quality-Systems-Assessment-Specialist-55531