Senior Quality Leader - Medical Device Manufacturing

Resonetics; Blaine (MN); On-site; USD 115,000 - 143,000; Full time

Job summary

Resonetics is seeking a Quality Manager to lead site quality and regulatory matters in Minnesota, overseeing customer interfaces, process validation, and continuous improvement initiatives.

The role requires extensive experience in medical device quality engineering, supervisory responsibilities, and strong technical writing skills. You will drive ISO compliance, audit readiness, and robust quality systems across the site.

Qualifications

• 8+ years in a Quality Engineering role for a medical device manufacturer and/or startup company or equivalent engineering experience.
• Demonstrated technical writing and communication skills.
• Working knowledge of Statistical software and/or Minitab.
• Bachelor’s degree or equivalent experience.
• Prior supervisory experience.

Responsibilities

• Liaising with customer quality personnel to resolve issues and customer complaints.
• Monitoring and disseminating customer quality report cards.
• Generating process deviations, validation protocols and reports.
• Generating Customer Change Notices.
• Assisting with troubleshooting of production and PDP processes.
• Leading development of metrology equipment.
• Developing and maintaining quality/control plans.
• Developing PFMEAs.
• Specifying metrology equipment.
• Conducting Gage R&R studies.
• Resolving Corrective and Preventive Actions.
• Developing Quality Procedures and ensure training of personnel.
• Approving Nonconformance disposition.
• Analyzing production and validation data.
• Working on continual improvement and process assessment projects as assigned.
• Supervising quality department for a site.
• Responsible for facilitation of external and/or internal audits.

Skills

Quality engineering

Statistical software

Supervisory experience

Technical writing

Education

Bachelor’s degree or equivalent experience

Tools

Minitab

Job description

Resonetics is seeking a Quality Manager to lead site quality and regulatory matters in Minnesota, overseeing customer interfaces, process validation, and continuous improvement initiatives.

The role requires extensive experience in medical device quality engineering, supervisory responsibilities, and strong technical writing skills. You will drive ISO compliance, audit readiness, and robust quality systems across the site.