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Senior Quality Engineer.  Nov. 28, 2009

Senior Quality Engineer
RESPONSIBILITIES:
1. Manage and/or coordinate all Victaulic’s corrective action systems to ensure quality issues do not re-occur. Some issues may require containment actions, root cause analysis, and follow up to be performed.
2. Support supplier quality initiatives, as directed by the Directory of Global Quality and Process Technology
3. Perform special projects as assigned by the Director, Global Quality and Process Technology.
4. Responsible for coordinating efforts to reduce the cost of poor quality.
5. Provide continuous support of Victaulic’s Product Delivery System implementation, and serve as department liaison for all related systems and staff training requirements.
6. Actively participate in product design reviews focused on Advanced Quality Planning, process FMEA’s, mistake proofing and other quality improvement methods such as the QCPC and Quality Clinic.
7. Manage the development and maintenance of internal technical specifications and testing methods commensurate with tolerance sensitivities and part complexity.
8. Initiate product / process reviews related to warranty claims/customer complaints.
9. Perform trend analysis and establish ongoing manufacturing / quality metrics.
10. Conduct routine product reviews through audits of the related manufacturing processes.
11. Initiate periodic communication with customers to ensure quality objectives are clearly identified and acted upon.
12. Identify new technologies for automating in-process inspections.
13. Globally supervise Supplier Quality engineers.

QUALIFICATIONS:
1. Engineering degree required. Materials, Metallurgical, or Mechanical Engineering degree preferred.
2. 7+ years experience in Manufacturing and Engineering / Quality.
3. Familiarity with statistical concepts and their application (control charts, process capability etc.) Knowledge in advanced statistical methods preferred.
4. Proficient in problem-solving.
5. Proficient in the use of electronic systems and software (MS Word®, Excel®, Lotus Notes®, MiniTab). Experience with SolidWorks a plus.
6. Knowledge of mechanical joining and piping solutions desired.
7. Good communication skills.
8. Working knowledge of measuring equipment.
9. Able to make independent decisions without supervisory assistance.
10. Able to travel globally as required, up to 25%.
11. Current or prior ASQ CQE and/or CSSBB certification desired.
12. Able to manage multiple projects simultaneously.

For more info, click here:
http://tbe.taleo.net/NA11/ats/careers/requisition.jsp?org=VICTAULIC&cws=1&rid=198

Quality/ Manufacturing Professional, Orange County, CA.  Nov. 28, 2009

Quality/ Manufacturing Professional
Orange County, CA
Perm Position 120K+
Six Sigma Master Black Belt
Aerospace/ Medical Background
Heart Valve Company in Orange County, CA

For more info please contact:

Mike Cray
ETG
Technical Recruiter
mike.cray@etgjobs.com
888-355-4345
480-355-4353 

 Principal Quality Engineer-Risk Management, Boston Scientific.  Nov. 28, 2009

Principal Quality Engineer-Risk Management-Must have Medical Device exp.
Relocation Covered
Principal QE - Risk Management - 29194

Delivering on the promise of medical innovation begins at Boston Scientific

By delivering innovative products that help clinicians improve the lives of patients every single day, Boston Scientific makes a profound impact on the quality of medical care around the world. As we continue to transform the field of medical technology, we seek dedicated individuals who possess the integrity and creative spirit needed to thrive in an innovative company. Join a global organization that is fueled by the diversity and talent of its entire workforce.

Job Purpose
Assist in the drafting of a new Risk Management systems strategy (and subsequent execution of that strategy) for BSC.

Key Responsibilities
* Assists in and manages functional and team deliverables.
* Ensures that contributions maximize Risk Management systems compliance to regulatory requirements, as well as drive efficiency and excellence in product development and commercialization environments.
* Provides guidance and approval (as applicable) regarding risk management strategies and approaches.
* Assists in communication of Risk Management team objectives, goals, and subsequent conclusions with (at a minimum) their home function. Communication responsibilities may extend out to include other business units, divisions, etc. depending on how individual is assigned to a role on the final team.
* Maintains and enhances cross-functional team relationships. This will include working with other Project Horizon teams to insure a real-time communication of issues as related to Risk Management.
* Work with quality system owners/stewards on strengthening the connection of Risk Management to their element(s) of the quality system
* Works cross-functionally in identifying and resolving technical issues including modeling activities for the core and/or integrated systems, using project/site/quality system data to ensure effectiveness of the Risk Management system prior to global roll out.
* Monitors and evaluates project progress and results as assigned.
* Provide coaching to other functional groups on elements of Risk Management activities

Qualifications
Preferred qualifications include:
* 6+ years BSC and/or equivalent medical device industrial experience, with heavy emphasis on usage of Risk Management toolbox (ex: FMEA, FTA, and other Risk Management & Analysis tools.)
* Basic experience with risk management planning and reporting per ISO 14971
* Proficient, working understanding of primary external regulatory guidance documents around Risk Management (ex: ISO 14971)
* Strong systems engineering background * either through educational experience, industrial experience, or both. Examples of systems engineering might come from systems architecture training, product development using a formalized stage gate or iterative process, process mapping training, etc.
* Excellent communication skills * must have experience creating PowerPoint presentations and speaking in front of 20+ people. Must be willing to act as primary communication conduit for their respective function and/or division.
EMAIL: thellen@validant.com
Phone: 415-400-2609


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