Senior Quality Engineer

One of the leading medical device manufacturers in the U. S. is seeking a Sr Quality Engineer to be responsible for providing new product development Quality Engineering leadership and support. Additionally, this position will functions as a subject-matter expert / resource for Engineering, Operations, Sterilization and outside suppliers.


DUTIES INCLUDE:

 Ability to perform engineering work of a broad nature with little or no direction from Quality Management.  Generally, receives guidance on novel or controversial problems.
- Extensive knowledge of medical device regulation, industry or international standard, including management responsibility.  Ability to understand Division and Plant Quality Systems and be able to implement systemic changes to enhance product quality and improve business efficiency.  Ability to interface with regulatory bodies to present technical information.
- Comprehensive knowledge of quality systems and relationship to business.
- Has experience in writing protocols/validations and has fundamental knowledge of validation principles.
- Understands basic applied statistics, statistical sampling plans, and statistical process control and advanced statistical methodologies such as DOE and Taguchi.
- Ability to serve in leadership roles on projects or assignments.
- Comprehensive understanding of auditing principles and ability to perform as a lead auditor.
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EDUCATION and EXPERIENCE

** A Bachelor degree in science or engineering with four (4) years of engineering experience within the medical device or equivalent regulated industry OR
** Master degree with three (3) years of engineering experience within the medical device or equivalent regulated industry
**American Society of Quality (ASQ) certification (CQE, CQA, CQM, etc.) a plus

*The above experience must include two (2) years of proven and effective project management skills.