Quality Engineer I

Resonetics, LLC; New Chicago (OH); On-site; USD 54,000 - 84,000; Full time

Benefits offered by this job

Medical Insurance

401(k)

Paid Time Off

Dental & Vision Insurance

Flexible Spending Accounts

Life Insurance

AD&D Insurance

Holidays

Job summary

Resonetics is seeking a Quality Engineer I to join our team in Kettering, OH. This role applies quality engineering methods to ensure compliance with ISO 13485 and regulatory standards across product development and manufacturing processes.

You will support risk management, root-cause investigations, and process validation, with opportunities to contribute to CAPA programs, data analysis (Minitab), and cross-functional reviews in a fast-paced medical-device environment.

Qualifications

• 1-3+ years’ experience in a Quality Engineering role in regulated manufacturing
• Experience creating job-related quality documentation
• Demonstrated technical writing and communication skills
• Working knowledge of statistical software (Minitab)

Responsibilities

• Apply quality engineering methods to identify and implement product or process improvements
• Develop risk documentation (PFMEAs) and implement risk mitigation tools
• Lead or contribute to root cause investigations and CAPA effectiveness assessments
• Develop/test methods and participate in product/process qualifications/validations
• Maintain process controls and quality control plans in proportion to risk
• Support ISO 13485 compliance across manufacturing and product development
• Participate in design/technical reviews and audits as SME
• Liaise with customers to resolve issues and manage customer complaints
• Generate process deviations and change notices; troubleshoot production and development processes
• Ensure QMS procedures and industry standards are followed throughout development and manufacturing
• Disposition nonconforming product; identify continual improvement projects
• Author protocols and reports and analyze production/validation data

Skills

Quality Engineering

Technical Writing

Statistical Analysis

Regulatory Knowledge

Education

Bachelor's degree in engineering or scientific discipline

Tools

Minitab

Job description

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.

Join Resonetics and be part of a team that’s redefining medical device manufacturing. If you’re passionate about innovation and thrive in a fast-paced environment, we’d love to hear from you.

Responsibilities

• 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 tools. Develop Corrective Action plans and assess 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.
• Liaising with customers to resolve issues and Customer Complaints.
• Generating process deviations & Customer Change Notices.
• Assisting with troubleshooting of production and product development processes.
• Ensuring QMS procedures and appropriate regulations and industry standards are being utilized throughout product and process development, and manufacturing.
• Dispositioning nonconforming product.
• Identifying and working on continual improvement projects.
• Author protocols and reports or provides support in performing related qualification activities. Analyzing production and validation data.

Required Qualifications

1-3+ years’ experience in a Quality Engineering role in regulated Manufacturing environment with preference for experience with Medical Device.

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 scientific discipline, or equivalent experience.

Preferred Qualifications

Familiarity with ISO Quality Systems, particularly ISO13485.

Use of optical inspection equipment. This may be defined as a magnifier, microscope, and/or equipment used for measuring capacity.

Physical Demands

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.

Compensation

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

Resonetics offers a comprehensive benefits package designed to support the health, well-being, and financial security of our employees and their families. Benefits include medical, dental, and vision insurance; a 401(k) retirement plan; paid time off (PTO); 10 paid holidays; Flexible Spending Accounts (FSA); life and Accidental Death & Dismemberment (AD&D) insurance; Short-Term Disability (STD) and Long-Term Disability (LTD) insurance; accident, critical illness, and hospital indemnity insurance. Eligibility and benefit offerings may vary based on employment status and applicable plan provisions.