Senior Quality Engineer (MFG)

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!

 

POSITION:  Senior Quality Engineer (MFG)

 

JOB SUMMARY:

The Sr. Quality Engineer will primarily work with Volcano’s 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 activitiesWorks 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 teamsPrepares 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 suppliersDevelops 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 requirementsRequires 5 - 8+ years experience in quality assurance in the medical device industryTraining and Experience leading and conducting supplier auditsWorks with Manufacturing through the NCR process to resolve supplier failuresWorks with R&D and Manufacturing to qualify new suppliersStrong 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 attitudeDemonstrated 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

LICENSES AND CERTIFICATIONS:Certified Quality Engineer, preferredCertified Quality Auditor, preferred

ADDITIONAL DESIRABLE QUALIFICATIONS:  Knowledge of HALT and HAST testingKnowledge or experience using Agile and MFGProGreen or Black Belt desirableQuality System program knowledge and understanding (e.g., QFD, Six Sigma, TQM)Experience using Jmp statistical software

SKILLS AND ABILITIES:  Ability to communicate effectively both orally and in writing and to establish and maintain cooperative working relationships with persons contacted in the course of performing assigned duties including Company management and outside business associates.Ability to organize and prioritize workflow and to meet established timeframesAbility to maintain updated knowledge of procedures, products and activities of assigned areaAbility to interact with senior management on a regular basis and maintain confidentiality.

PROBLEM SOLVING AND DECISION MAKING:  Develops solutions to a variety of problems; ensures solutions are consistent with organization objectives

TRAVEL REQUIREMENTS:  Will be required to travel both domestically to Volcano offices or customer and supplier locations (5%).

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.