Quality Engineer I

Resonetics•Dayton, OH

17h•$54,000 - $84,000•Onsite

About The Position

Resonetics is seeking a Quality Engineer I to join its team in Kettering, Ohio. The role applies quality engineering principles, scientific methods, relevant regulations, standards, and industry best practices to daily work. The engineer plans and conducts assignments with moderate to high technical responsibility, complexity, or strategic input, receiving summarized instructions from technical Quality leaders and other functional stakeholders. The position supports product and process development and manufacturing in the medical device industry.

Requirements

1–3+ years of experience in a Quality Engineering role in a regulated manufacturing environment; medical device experience is preferred.
Ability to create job-related quality documentation.
Demonstrated technical writing and communication skills.
Working knowledge of statistical software and/or Minitab.
Bachelor’s degree in engineering or a scientific discipline, or equivalent experience.
Must already be legally authorized to work in the United States without current or future visa sponsorship.

Nice To Haves

Familiarity with ISO Quality Systems, particularly ISO 13485.
Experience using optical inspection equipment, such as a magnifier, microscope, and/or equipment used for measuring capacity.
Experience in the medical device industry.

Responsibilities

Apply tools and methods to support new product or process introductions and business improvements.
Develop risk documentation, including PFMEAs, in compliance with the QMS and regulatory standards, and contribute to risk management and mitigation.
Lead or contribute to root cause investigations using problem-solving techniques and tools; develop corrective action plans and assess their effectiveness.
Conduct or support test-method development, including TMV and Gage R&R studies, for equipment, process, and product qualifications and validations.
Develop, implement, and maintain risk-proportionate process controls and quality control plans using appropriate techniques, such as statistical process control and statistical inspection sampling.
Support all levels of manufacturing per ISO 13485.
Participate in design and technical reviews as appropriate.
Act as a subject matter expert in audits when needed.
Liaise with customers to resolve issues and customer complaints.
Generate process deviations and Customer Change Notices.
Assist with troubleshooting production and product development processes.
Ensure QMS procedures and applicable regulations and industry standards are used throughout product and process development and manufacturing.
Disposition nonconforming product.
Identify and work on continual improvement projects.
Author protocols and reports or support related qualification activities; analyze production and validation data.