Sr. Quality Engineer

Apply by eMail:15224620.185@jobfrenzy1.com

Description:
Position Purpose:

Provide oversight of Sterilization Quality for Ethylene Oxide Processing in North America. This includes review of operational sterilization metrics to include Non Conforming Material run rate, management of the objectives to improve metrics and advocating of zero non conformance mind set.

Expectations:

- Conduct regular reviews of sterilization run data and identify objectives to implement improvements for elimination of non conformances.

- Conduct reviews and assist to assure compliance and readiness for external audits that are conducted at Boston Scientific.

- Manage the assigned Sterilization Department Projects; review of data using statistical techniques.

- Lead cycle optimization efforts, annual verification of validation, and cycle consolidation efforts for Boston Scientific.

- Cycle analysis of sterilization data to identify systemic concerns and improvements to sterilization cycle to support cycle parameters and release of product.

- Conduct analysis associated with cycle specifications to set up programs for parametric release for Boston Scientific.

Qualifications/Education/Experience Required:

This position requires knowledge and ability typically associated with a Bachelor's degree in Engineering or related science. Also required is 6+ years of relevant experience such as, project management, six sigma methodologies, and statistical methods. Other skills include a Black Belt in Six Sigma, Sterilization knowledge, and medical devices experience, but are preferred.

Principal Accountabilities:

30% Coordinate the implement of Lean Six Sigma Process Management, leading to the improvement of both the stability and variability of customer CTQ’s at Contract EO Sterilization Facilities. This may include the provision of on-site training and tools to facility practice.

20% Collect data from sterilization systems and perform analysis leading to improvements to sterilization methodologies.

20% Participate in projects leading to the creation of systems for the release of products from sterilization to include parametric release.

20% Review data to make recommendations surrounding the optimization of sterilization cycles.

10% Set direction for corporation by conducting research and recommending to management and teams more innovative ways to conduct day to day business.

Requirements:
Qualifications/Education/Experience Required:

This position requires knowledge and ability typically associated with a Bachelor's degree in Engineering or related science. Also required is 6+ years of relevant experience such as, project management, six sigma methodologies, and statistical methods. Other skills include a Black Belt in Six Sigma, Sterilization knowledge, and medical devices experience, but are preferred.

Education: Bachelor

Experience: More than 5 years

Travel: None

Apply by eMail:15224620.185@jobfrenzy1.com

Job Created: Sun Sep 27 2009 04:27:03 AM
Last Modified: Sun Sep 27 2009 04:27:03 AM