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Engineer II - III, Quality

Description Job Summary: Responsible for performing various Quality Engineering Activities whose main purpose is to facilitate continuous improvement for both products and processes and to support new product/process development activities.  These activities include process validation, defect analysis and corrective action, new product evaluation, performing internal and supplier audits to verify compliance with ISO and FDA/QSR Regulations, personnel training, and developing and implementing improved test and measurement techniques.  Duties and Responsibilities: Write/execute design verification and/or process validation protocols. Preparation and analysis of periodic Quality Reports. Performing internal audits of products and processes.  Selection, Qualification and monitoring of outside suppliers.  Preparation of test and inspection procedures.  Preparation of Engineering Changes.  Provide training and direction to manufacturing and QA personnel.  Participate in MRB meetings.  Perform system and component defect analysis in conjunction with the continuous improvement program. Ensures that appropriate Risk management systems and programs are in place and effective. Function as department supervisor on occasion of the Director's absence. Ensures that appropriate Risk management systems and programs are in place and effective. Requirements: BS Degree in an Engineering discipline or equivalent experience. 5 years minimum experience in manufacturing and Quality Assurance of medical devices.  CQE preferred. Strong basic statisticsexperience. Conversant with software applications for Microsoft Windows including Word, Excel, and Access. Ability to communicate effectively with personnel at all levels both verbally and in writing. A self starter able to function independently with minimum direction and to act on behalf of the Quality Manager in his/her absence. Benefits: Company Matched 401k Tuition Reimbursement (Up to $5,250 per year) 3 Weeks Vacation plus 8 sick days Medical / Dental / Vision Life, STD, LTD & LTC Insurance Leadership Development (not for every position - management only) Green Belt / Black Belt Certification Programs - KSE KARL STORZ University and other training and development programs. Fitness Reimbursement $200 Section 125 Flexible Spending Accounts 401K, company matches 60% up to 6% of your annual income $1,000 Referral Bonus 9494
Salary Range: NA
Minimum Qualification
5 - 7 years

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