Remote-Ready Quality Engineer: Supplier & Product Quality

Smartvest; New Prague (MN); On-site; USD 70,000 - 118,000; Full time

Benefits offered by this job

Discretionary Time Off

Employee bonus plan

Hybrid/Remote options

Paid parental leaves

Recognition program

Training opportunities

Educational assistance

Well-being on demand

Perks at Work

Health benefits + HSA

401(k) match

Great culture

Job summary

Electromed in New Prague, MN is seeking a Quality Engineer to strengthen supplier quality, incoming quality, complaint handling, and product quality trending. You will partner with suppliers, Operations, Regulatory, Design Assurance, and Document Control to identify, investigate, and resolve quality issues across materials, released product, and field performance.

The role requires a Bachelor’s degree and 2+ years in a hands-on quality role, with knowledge of ISO9001-based systems and FDA 21 CFR

Qualifications

• Bachelor’s degree required.
• 2+ years in a hands-on quality role; medical device manufacturing preferred.
• Experience with ISO9001-based quality systems (ISO13485, AS9100, IATF16949).
• ASQ certs preferred (CQE, CQA, CSQP, CSSGB etc.).
• Knowledge of CAPA, deviation, nonconformance processes.

Responsibilities

• Collaborate with suppliers to resolve root causes of nonconforming material.
• Administer MRB process for disposition of rejected material.
• Manage supplier quality performance metrics and scorecards.
• Lead supplier audits and CAPA activities.
• Process customer complaints per established procedures.
• Assist with data analysis to identify quality trends and risks.
• Support internal/external audits and quality documentation.

Skills

Root cause analysis

CAPA

Statistical methods

Quality systems

Cross-functional communication

Travel (≤10%)

Education

Bachelor’s degree

Tools

ISO13485

Job description

Electromed in New Prague, MN is seeking a Quality Engineer to strengthen supplier quality, incoming quality, complaint handling, and product quality trending. You will partner with suppliers, Operations, Regulatory, Design Assurance, and Document Control to identify, investigate, and resolve quality issues across materials, released product, and field performance.

The role requires a Bachelor’s degree and 2+ years in a hands-on quality role, with knowledge of ISO9001-based systems and FDA 21 CFR