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QUALITY ENGINEER I

Indianapolis, IN


The Role

The Quality Engineer will be responsible for developing and maintaining quality engineering methodologies and providing quality engineering support with R&D, manufacturing, and/or clinical teams. This role will identify and implement effective process control systems to meet or exceed both internal and external requirements. You will lead the implementation of assurances, process controls, and CAPA systems.


The Quality Engineer will assist in the development and execution of streamlined business systems issues applying systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues. You will design and conduct experiments in process optimization and improvements, ensuring that appropriate documentation experiment plans and results, including protocol and written reports, are added to the company’s QMS, as well as participate in (or lead) teams in supporting quality disciplines, decisions, and practices.


As a quality professional, you will provide solutions to a wide range of difficult problems related to the quality and regulatory aspects of design, validation, and manufacturing Class I and II medical products. You will serve as the owner and administrator of several aspects of our quality system, including but not limited to supplier management, process control, statistical techniques, and design control.


Responsibilities

  • Provide quality engineering floor support for production area to ensure production is able to expand capacity and volumes

  • Document, evaluate, and disposition any non-conformance associated with production

  • Initiate, identify root cause, evaluate, and document corrective and preventative action following the Quality Management System requirements for CAPA

  • Ensure that the quality reporting (e.g., incoming and in-process quality trends; returns analysis, categorization, and corrective action activity, etc.) is maintained and documented with the assigned team

  • Document, evaluate, and record process validation protocols, testing, and reports for process optimization related to current production and future production of new designs

  • Complete inspection and evaluation of finished products

  • Ensure full conformance to specification requirements

Qualifications

  • Bachelor’s degree in engineering, physics, chemistry, biology, or related science required

  • Considerable hands-on experience in medical device manufacturing

  • 1-3 years in Medical Device/Biologics manufacturing experience preferred

  • Demonstrated ability to work in multi-departmental project teams and resolve quality-related issues in a timely and effective manner

  • Strong working knowledge of FDA QSR and ISO 13485

  • Strong written and verbal communication skills


The Company

Welcome to an established company, with a proven product, and a start-up feel. Sonablate Corp. was created following an acquisition of SonaCare Medical, LLC in 2021. We have designed, developed, manufactured, sold, and serviced the Sonablate HIFU ablation device for over two decades, receiving 510K de novo clearance with the FDA in 2015. The Sonablate device is cleared in more than 50 countries, including a CE Marking in the European Union and approval from the National Medical Products Administration in China.


Sonablate Corp. has two offices: one in Charlotte, NC and the other in Indianapolis, IN as well as remote employees spread out across the country. We stay focused by having monthly town hall meetings, tracking our progress toward annual goals, and passing all new projects through a rigorous vetting by our prioritization committee. We strive for transparency and clear communication throughout the company and look for candidates that want to dive in, effect change, and challenge us to become the best version of ourselves.


Our employees enjoy competitive salaries, bonus plans, and an employee stock option plan. Additionally, the company pays for 90% of the employee’s healthcare benefits, which are effective the first of the month following your first day on the job. We offer flexible working schedules for our hourly employees and a work-from-home policy for our salaried ones. We believe in giving our employees autonomy, mastery, and purpose and enjoy low turnover due to that philosophy.

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.



Equal Opportunity Employer




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