Quality Engineer: Supplier & Product Quality Leader

Electromed, Inc.; New Prague (MN); Hybrid; USD 70,000 - 118,000; Full time

Benefits offered by this job

Discretionary Time Off

Employee bonus plan

Flexible hybrid/remote work options

Parental leave benefits

Training opportunities

Job summary

Electromed, Inc. in New Prague, MN seeks a Quality Engineer to support supplier quality, incoming quality, and complaint activities.

You will analyze data, drive root-cause investigations, manage MRB dispositions, and partner across Operations, Regulatory, and Design Assurance to improve product quality and compliance. The role requires a Bachelor's degree and 2+ years in quality, with strong communication and problem-solving skills.

Qualifications

• Bachelor’s degree from an accredited college or university.
• 2+ years of hands-on Quality experience in supplier quality, incoming quality, complaints, nonconformance, or related activities.
• Experience with ISO9001-based standards (ISO9001, ISO13485, AS9100, or IATF16949).
• ASQ certification such as CQE/CSQP/CQA or similar preferred.
• Knowledge of ISO14971, ISO13485:2016, and FDA 21 CFR 820 preferred.
• Familiarity with Six Sigma problem solving tools.
• Good communication and multitasking abilities.

Responsibilities

• Collaborate with suppliers to resolve root causes of nonconforming material.
• Administer MRB process for disposition of rejected material.
• Maintain supplier quality performance metrics and scorecards.
• Lead audits and supplier re-evaluations.
• Support supplier corrective actions and investigations.
• Analyze incoming quality data for trends and risks.
• Support complaint handling and quality issue investigations.
• Participate in CAPA, deviation, and quality improvement activities.
• Interact with regulatory bodies during audits as needed.

Skills

Supplier quality

Quality metrics

Root cause analysis

CAPA

Quality auditing

Statistical methods

Cross-functional collaboration

Excellent communication

Education

Bachelor's degree

Tools

ISO9001

ISO13485

FDA knowledge

Job description

Electromed, Inc. in New Prague, MN seeks a Quality Engineer to support supplier quality, incoming quality, and complaint activities.

You will analyze data, drive root-cause investigations, manage MRB dispositions, and partner across Operations, Regulatory, and Design Assurance to improve product quality and compliance. The role requires a Bachelor's degree and 2+ years in quality, with strong communication and problem-solving skills.