Quality Engineer

Overview

Resonetics is a global leader in advanced engineering, prototyping, product development, and micro‑manufacturing, driving innovation in the medical device industry. With rapid expansion across all our locations, we continue to push the boundaries of technology while fostering a dynamic, employee‑centered culture. Our commitment to excellence and continuous improvement makes Resonetics an exciting place for professionals passionate about shaping the future of micro‑manufacturing and being part of something bigger.

We are looking for a Quality Engineer I to join our growing team in Kettering, OH. This role applies Quality Engineering and scientific method techniques and principles to daily tasks and activities; applies relevant regulations, standards, and industry best practices to assignments; plans and conducts projects and assignments with moderate to high technical responsibility, complexity or strategic input; receives summarized instructions from technical Quality leaders at various levels in addition to other functional stakeholders.

• Demonstrates proficiency in applying various tools and methods to identify and realize new product or process introductions (ex. QMS, product related), and business improvements.
• Developing risk documentation such as PFMEAs in compliance with the QMS and regulatory standards. Contributes to the application of various risk management and risk mitigation tools and practices.
• Leads and/or contributes to root cause investigations using various problem‑solving techniques and develops corrective action plans and assesses for effectiveness.
• Conducts and supports the development of test methods (TMV / Gage R&R studies) in equipment, process, and product qualifications/validations.
• Develops, implements and/or maintains process controls & quality control plans in proportion to risk using appropriate techniques and tools (ex. Statistical process controls, statistical inspection sampling).
• Supports all levels of manufacturing per ISO 13485.
• Participates in design/technical reviews as appropriate.
• May act as a subject matter expert (SME) in audits.
• Liaises with customers to resolve issues and customer complaints.
• Generates process deviations & customer change notices.
• Assists with troubleshooting of production and product development processes.
• Ensures QMS procedures and appropriate regulations and industry standards are being utilized throughout the product development and process development, and manufacturing.
• Identifies and works on continual improvement projects.
• Authors protocols and reports or provides support in performing related qualification activities.
• Analyzes production and validation data.

• 2+ years’ experience in a Quality Engineering role in a regulated manufacturing environment with a preference for medical device experience.
• Ability to create job‑related documentation for quality purposes.
• 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.

• Familiarity with ISO quality systems, particularly ISO 13485.
• Experience with optical inspection equipment such as a magnifier, microscope, and/or equipment used for measuring capacity.

• Light office work only; position may include up to 10% domestic and international travel.
• Standing and walking for short periods of time.
• Ability to use a microscope, including manipulating small objects under a microscope.

The compensation for this role is competitive and will be based on experience and qualifications. The anticipated range is $54,000–$84,000.

For temp, temp‑to‑hire, and regular full‑time positions, our company policy is that we are unable to provide visa sponsorship. Candidates must already be legally authorized to work in the United States without the need for sponsorship now or in the future.