Quality Engineer

We are seeking a highly motivated Quality Engineer to support our medical device component manufacturing operations while contributing to engineering activities across both medical device and aerospace projects. This role requires a strong background in quality systems, process validation, failure analysis, and manufacturing support.

The successful candidate will work closely with engineering, production, quality, and customer teams to ensure products meet regulatory, customer, and internal quality requirements.

This position offers a unique opportunity to work in a hybrid Quality Engineer / Production Engineer capacity, supporting both regulated medical device manufacturing and aerospace development and testing programs.

Essential Duties and Responsibilities

Quality Engineering

• Maintain and continuously improve Quality Management System (QMS) processes in compliance with ISO 13485 and applicable customer requirements.
• Support internal, supplier, and customer audits.
• Develop, review, and maintain quality procedures, work instructions, forms, and records.
• Participate in root cause investigations and implementation of Corrective and Preventive Actions (CAPA).
• Manage nonconforming material investigations and disposition activities.
• Support risk management activities and quality planning throughout product development and production.

Validation and Process Qualification

• Develop, execute, and document Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols.
• Analyze validation data and prepare validation reports.
• Support process validation activities for manufacturing equipment, tooling, and production processes.
• Ensure validation activities comply with customer, regulatory, and internal requirements.

Failure Analysis and Continuous Improvement

• Conduct product and process failure investigations using structured problem-solving methodologies.
• Utilize quality tools including 8D, 5 Whys, Fishbone Diagrams, FMEA, SPC, and statistical analysis techniques.
• Lead quality improvement initiatives focused on reducing defects, improving yields, and increasing process capability.
• Prepare technical reports and communicate findings to customers, management, and cross-functional teams.

Production Engineering Support

• Provide engineering support for daily manufacturing operations.
• Troubleshoot production issues and implement effective corrective actions.
• Develop and optimize manufacturing processes, work instructions, and process controls.
• Support new product introductions (NPI), manufacturing transfers, and continuous improvement initiatives.
• Collaborate with production personnel to improve efficiency, quality, throughput, and overall manufacturing performance.

Qualifications

• Bachelor's degree in Engineering, Manufacturing Engineering, Mechanical Engineering, Quality Engineering, Aerospace Engineering, or a related technical field.
• Minimum of 3 years of experience in quality engineering, manufacturing engineering, or a related role.
• Experience working within medical device manufacturing environments and/or ISO 13485 Quality Management Systems.
• Demonstrated experience with IQ/OQ/PQ process validation activities.
• Experience conducting root cause analysis, failure investigations, and corrective action implementation.
• Working knowledge of CAPA, FMEA, SPC, statistical analysis, and continuous improvement methodologies.
• Ability to read and interpret engineering drawings, specifications, and technical documentation.

Key Competencies

• Strong analytical and problem-solving skills.
• Attention to detail and commitment to product quality.
• Ability to manage multiple projects and priorities simultaneously.
• Effective collaboration across engineering, production, quality, and customer teams.
• Self-motivated with a continuous improvement mindset.
• Ability to work independently while contributing to a team environment.

Benefits

• Health care insurance benefits available first of the month following 60 days of employment. Thirty (30) hours worked per week must be averaged in order to maintain coverage. 401k enrollment is available per the Secure Act guidelines. Earned Sick and Safe time is accrued and can be used per the State of MN guidelines. #IND
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