Volcano Corporation is dedicated to developing breakthrough technologies that save people's lives and enhance their current quality of life! At Volcano you will find a pioneering and innovative spirit with a wide range of opportunities.
Without the exceptional professionals at Volcano Corporation, we simply could not fulfill our mission to improve the lives of patients worldwide.The Product Assurance department in Volcano Corporate is a technical Quality function focused on assuring that high quality/compliant engineering practices are used in the development, testing, manufacture and servicing of Volcano's medical devices. The Design Assurance group within the product assurance department includes Quality Engineers that provide compliance direction and independent review/approval for technical activities during the design/development of medical devices. Their overall responsibility is to ensure that generated documentation/artifacts meet regulatory requirements and can be audited by regulatory authorities to show compliance to the applicable regulations.
Specifically, this Quality Engineer will:
Be dedicated to design and development projects prior to product commercialization
Have daily interaction peer group - R&D Engineering
Provide expertise in design controls (21CFR820.30) and product realization (ISO13485)
Provide expertise in DHF, Tech File, Design Dossier documentation and Design Risk Management activities
DUTIES AND RESPONSIBILITIES:
Developing /delivering design assurance artifacts required by PDP/design controls
Facilitating Risk Management activities
Understanding design control compliance req's
Ensuring design control requirements are met
Confirming compliance of DHF to requirements
Providing documented approval of DHF artifacts
Product/complaint investigations (as needed)
Inspection and/or evaluation techniques for determining levels of quality during the receipt, manufacture and final test of product (post design transfer)
Equipment, fixtures and methods required to perform inspections, including gage R&R's
First article inspections and results
Any unique controls needed to ensure proper software versions are controlled and properly issued to manufacturing
Confirm and/or establish statistically valid sample sizes for design and process V&V's
Review/approve DHF artifacts to ensure compliance and defensibility
Perform periodic audits of the DHF to evaluate conformance to SOPs & WIs
Perform or contribute to root cause investigations of commercialized product where design issues are suspected
CAPA activities as required
Qualifications:
MINIMUM QUALIFICATIONS, KNOWLEDGE, SKILLS AND ABILITIES:
Bachelor's degree in BME, ME or a related field
10-12 years of experience in Quality Engineering
6-8 years' experience in disposables quality engineering in the medical device industry, particularly in implantable medical device design controls and product realization
DESIRABLE QUALIFICATIONS:
Experience in establishing design control requirements and processes for implantable medical devices
Six-sigma black belt
OTHER PARTICULARS:
Must provide initial on-site support in the Menlo Park office through the transition of manufacturing to the Rancho Cordova and/or Costa Rica facilities. Estimated to be through July 2013
PHYSICAL DEMANDS:
Must be able to lift 30 lbs
Must be able to sit/stand for extended periods of time
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.
Headquartered in San Diego, CA, Volcano maintains expansive facilities housing engineering, laboratory, manufacturing, and production operations in Northern California, Costa Rica, and various locations worldwide. Volcano is an Equal Opportunity Employer. It is the policy of Volcano Corporation, to base all employment decisions on the principles of equal employment opportunity and to take affirmative action in the employment of women, minorities, individuals with disabilities, and veterans.
