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QUALITY ASSURANCE SPECIALIST

Indianapolis, IN


Summary

The QA Specialist is responsible for facilitating the quality review program and ensuring that product integrity and standards are being met. The QA Specialist’s responsibilities include developing and implementing quality assurance policies, conducting tests and inspections, identifying production, process, or product issues, and presenting solutions.


Duties and Responsibilities

Monitoring, cumulating quality data, and coordinating quality review meetings.


Preparing and implementing quality assurance policies and procedures.


Performing routine inspections and quality tests.


Identifying and resolving workflow and production issues.


Ensuring that standards and safety regulations are observed.


Addressing and discussing issue and proposed solutions with superiors.


Documenting quality assurance activities and creating reports.


Overseeing the scheduling and execution of internal audits.


Making recommendations for improvement.


Creating training materials and operating manuals.


All other duties, as assigned.


Qualifications/Specifications

AS Degree or equivalent work experience, required. BS degree or equivalent work experience, preferred.


4 or more years of experience in the medical device, electronics, or related industry; preferably with electro-mechanical devices.


Certificate in Quality Assurance, a plus


Previous experience in quality assurance, preferably with Class II medical devices and familiarity with FDA Quality System Regulation and ISO 13485.


Working knowledge of tools, methods, and concepts of quality assurance.


Solid knowledge of relevant regulatory standards.


Good communication skills, both verbal and written.


Excellent data collection and analysis skills.


Strong attention to detail.



Sonablate provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state, and local laws.






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