Quality Engineer I

Overview

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.

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.