Avoid scams and fraud by dealing locally! Beware any deal involving Western Union, Moneygram, wire transfer, cashier check, money order, shipping, escrow, or any promise of transaction protection/certification/guarantee. More info
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:
Technical expert in area of document control to a growing, evolving medical device company. Provides guidance to document control staff. Develop and maintain device master records (DMR), device history records (DHR), design history files (DHF), engineering change orders (ECO), quality system manuals and other documentation systems.
RESPONSIBILITIES:
Oversees and manages document control staff.
Provides technical guidance on document control issues encountered with a growing medical device company
Provides expertise on integration of PLM (or document control software) software into a Quality System Software platform
Maintains Lot History, Design Review and specification records.
Identifies records retention and master device records, revision and location records.
Ensures records are backed-up as necessary to protect the Company’s investments.
Attends ISO design review and training meetings.
Maintenance of documentation required for FDA and ISO compliant manufacturing.
Implementation of policies needed to organize and maintain records, both electronic and paper.
Chairperson or lead for all Change Control Board (CCB) activities.
Maintain the document change control processes that involve the receipt, maintenance, approval, incorporation, affectivity of change, distribution, and storage of documents. This responsibility includes, but is not limited to; product specifications, customer specifications, standard operating procedures, manufacturing instructions, validations, protocols, deviations, investigations and standard QMS templates/forms.
Maintain configuration control of all build documentation. Responsibilities will include control of as-built configuration documentation, device history records (DHR), etc.
Department responsibilities include data entry, maintenance and revisions to product “bill of materials” for manufactured products. Ensures that all changes to documentation are implemented in an accurate and timely manner
EDUCATION:
Requires a BS degree, MS preferred
KNOWLEDGE & EXPERIENCE:
The successful candidate must have a thorough understanding of documentation requirements in accordance with ISO 13485:2003 and\or 9001:2000 – Quality
Management Systems and 21 CFR Part 820 – Quality System Regulation.
Minimum five (5) years experience involving document control activities.
Prior experience using electronic Quality System software (medical device or pharma)
Knowledge and demonstrated understanding of Good Manufacturing Practices (GMP’s)
The ability to enforce and audit conformance
Ability to effectively communicate directly with all levels of personnel.
Must exhibit computer proficiency with Microsoft Office, Excel, Access, etc.
SUPERVISORY RESPONSIBILITY:
Supervises nonexempt staff; makes hire, termination, promotion and merit decisions
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
Principals only. Recruiters, please don't contact this job poster.
Please, no phone calls about this job!
Please do not contact job poster about other services, products or commercial interests.