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Volcano Corporation provides rewarding and challenging employment opportunities for those qualified and selected individuals wishing to join us as we develop, market, and manufacture products that improve the overall quality of medical care.
Come join Volcano Corporation - a team leading the way!
JOB SUMMARY:
The Sr. Quality Engineer will primarily work with Volcanos Manufacturing, supporting electronic systems or disposable catheter manufacturing. These include new product launch teams, manufacturing Quality improvement teams (utilizing Six Sigma and QIP tools), performing statistical analysis in verifications and validations, NCR, MRB and implementing corrective actions. Additionally the candidate will participate and or perform internal audits while presenting to all levels of the company.
RESPONSIBILITIES:
Participated in internal audits (GMP, ISO 13485) and completes all follow-up activities
Works with manufacturing to implement Quality Improvements (e.g., defect analysis, control charts, data analysis, lead Quality and CIP teams)
Participates in R&D new product launch teams
Prepares verification and validation protocol and reports.
Reviews and approves quality document changes (ECO, MCO, deviations).
Participates in the Material Review Board meetings to determine root cause failure and provide feedback to suppliers
Develops quality inspection criteria for incoming inspection and final inspection
EDUCATION:
Requires a Bachelor's degree in Engineering or equivalent training/experience
KNOWLEDGE AND EXPERIENCE:
Demonstrated knowledge and understanding of FDA regulations, Quality System Regulations (QSR), ISO 13485 requirements
Requires 5 - 8+ years experience in quality assurance in the medical device industry
Training and Experience leading and conducting supplier audits
Works with Manufacturing through the NCR process to resolve supplier failures
Works with R&D and Manufacturing to qualify new suppliers
Strong analytical skills with the application of statistical methods (e.g., SPC, DOE resulting from Risk Analysis is required.
Works with suppliers to test, validate, and qualify new procedures and equipment
Proven experience in leading others with a proactive attitude
Demonstrated knowledge and understanding of medical device standards for packaging, sterilization, biocompatibility, electrical safety, electromagnetic compatibility, and software.
Knowledge of computer applications (i.e.: Microsoft Word, Excel, PowerPoint, Access & Project, Windows, Visio, etc.) required
ADDITIONAL DESIRABLE QUALIFICATIONS:
Knowledge of HALT and HAST testing
Knowledge or experience using Agile and MFGPro
Green or Black Belt desirable
Quality System program knowledge and understanding (e.g., QFD, Six Sigma, TQM)
Experience using Jmp statistical software
TRAVEL REQUIREMENTS:
Will be required to travel both domestically to Volcano offices or customer and supplier locations (5%).
Volcano offers a competitive comprehensive Benefits Package to regular full time employees.
Qualified candidates please email resume to jobs@volcanocorp.com
To learn more about Volcano Corporation go to www.volcanocorp.com
EEO/AA M/F/V/D
NOTE: The above statements are intended to describe the general nature and level of work being performed by incumbents. They are not intended to be an exhaustive list of all responsibilities, duties and skills required by all incumbents. Incumbents may perform other duties as assigned. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Management retains the right to add to or change the duties of the position at any time.
Location: Rancho Cordova, CA.
Compensation: DOE
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