Quality Engineer I: Medical Device Quality & Process Improvement

Resonetics; Hutchinson (MN); On-site; USD 56,000 - 84,000; Full time

Job summary

Resonetics is seeking a Quality Engineer I to provide customer and factory facing quality support, assist with transitioning laser manufacturing processes, and sustain the Quality Management System. You will apply Lean Six Sigma, process validations, and risk management to ensure compliance with ISO 13485 and 21 CFR 820, while contributing to design controls and development projects.

You will interface with customers and suppliers quality organizations, lead root cause investigations, develop

Qualifications

• 0-2+ years’ experience in a Quality Engineering role for a medical device manufacturer and/or start-up company, or equivalent engineering 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 or equivalent experience.

Responsibilities

• Demonstrates strong proficiency in applying various tools and methods to identify and realize new product or process introductions (ex. QMS, product related), and business improvements.
• Leads and 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 and assesses effectiveness of corrective actions.
• Conducts and supports the development of test methods in equipment, process, and product qualifications/validations.
• Develops, implements, and/or maintains process Quality control plans are in accordance with product risk level and are followed.
• Develops, implements and/or maintains process controls using appropriate techniques and tools (ex. Statistical process controls, statistical inspection sampling).
• Supports all levels of Design Controls per ISO 13485:2016 and QSR 21 CFR 820.
• Participates in design/technical reviews as appropriate.
• Lead QE on product development projects.

Skills

Technical writing

Communication

Statistical software

Education

Bachelor’s degree or equivalent experience

Tools

Minitab

Job description

Resonetics is seeking a Quality Engineer I to provide customer and factory facing quality support, assist with transitioning laser manufacturing processes, and sustain the Quality Management System. You will apply Lean Six Sigma, process validations, and risk management to ensure compliance with ISO 13485 and 21 CFR 820, while contributing to design controls and development projects.

You will interface with customers and suppliers quality organizations, lead root cause investigations, develop