Senior Quality Engineer Job in San Diego 92011, California US
About Us
IRIS International, Inc. is a leader in in vitro diagnostic urinalysis systems, digital imaging software development, sample collection, sample processing and small benchtop centrifuges and supplies for chemistry, coagulation, cytology, hematology, and urinalysis for the clinical and veterinary markets. The Company operates through its Iris Diagnostics division, and its Iris Sample Processing (formerly Statspin®) subsidiary. The Company's stock trades on the NASDAQ under the symbol "IRIS".
Senior Quality Engineer
DescriptionBasic Job Function
Responsible for the maintenance and improvement of key Quality systems and processes as well as insuring that quality requirements are defined and met during design, development and release to manufacturing. The incumbent will work in a multidisciplinary environment requiring a broad range of experience, analytical, communications, and interpersonal skills.
Responsibilities/Duties Performed
1. Responsible for evaluating the scope of new programs, applicable regulatory and statutory requirements, and defining quality requirements. Insures that all requirements and deliverables are met during the design control process.
2. Plays a major role in the maintenance of an ISO 13485:2003 and QSR Compliant Quality Management System
3. Responsible for leading risk analysis activities on new development programs and may participate in ongoing risk management for products in production.
4. Works with RD and outside testing facilities to ensure that new products meet both domestic and appropriately identified international EMC and safety standards.
5. Responsible for preparing technical files and declarations of conformity to the In Vitro Diagnostics directive 98/79/EC and applications for Canadian Medical Device licenses.
6. Will have command of an appropriate set of mathematical, statistical and scientific problem solving knowledge to bring to bear on problems encountered.
Required ExperienceMinimum of 7 year's experience in quality management in an FDA-regulated environment, preferably in medical devices/IVDs.
Specific Skills/Knowledge
o ASQ Certified Quality Engineer, Certified Reliability Engineer, Certified Biomedical Auditor or Certified Internal Auditor, Strong QA Design experience are all highly desirable.
o Knowledge of FDA QSR is required.
o Knowledge of In Vitro Diagnostic Directive or Medical Device Directive is preferred.
o Strong understanding of the theory and implementation of Quality Management systems is required.
o Knowledge of descriptive statistics and basic mathematics of reliability required.
Required EducationBachelor's degree in a natural science or engineering discipline required, some graduate education preferredCompensationWe offer a lucrative compensation plan and full benefit package including medical, dental, 401 K and much more!CommentsTo apply, please submit your confidential resume and include your salary requirements and history.
Applications accepted only through our online website.
Only Qualified candidates will be considered.
NO PHONE CALLS Please.
NO AGENCIES
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