Software Quality Engineer

Job Duties

Seeking a Software Quality Engineer to provide quality engineering support for commercial medical device manufacturing. This role will focus on software validation, process validation, quality system compliance, and continuous improvement initiatives supporting manufacturing operations. This is an excellent opportunity for a quality-focused professional who enjoys working cross-functionally to support compliant, efficient, and high-quality medical device manufacturing processes.

Key Responsibilities

• Provide Software Quality Engineering support for commercial medical device manufacturing.

• Lead and support computer/software validation activities for production equipment and systems.

• Review and maintain validation documentation for software, processes, and manufacturing changes.

• Support investigations, root cause analysis, CAPA, NCMR, and change control activities.

• Collaborate with Engineering, Manufacturing, and Quality teams to ensure compliance with regulatory and quality requirements.

• Develop and maintain quality standards, procedures, and protocols.

• Perform statistical analysis and utilize quality tools such as FMEA, Six Sigma, DOE, and risk analysis.

• Ensure products and processes comply with FDA and international regulatory requirements.

• Support process validation, test method validation, and quality improvement projects.

Top Skills Needed

• Software/Computer Validation for manufacturing equipment.

• Medical device change control, CAPA, SPC, and quality systems experience.

• Strong analytical, technical writing, communication, and root cause investigation skills.

Minimum Education Required

• Bachelor's degree in Engineering, Quality, Computer Science, or related field.

Minimum Experience Required

Required Qualifications

• 2+ years of relevant engineering or quality experience.

• Experience with computer/software validation for manufacturing or production equipment.

• Experience with medical device change control processes.

• Knowledge of process validation, CAPA, NCMR, SPC, and root cause investigations.

• Working knowledge of FDA QSR 21 CFR 820 and ISO 13485:2016.

• Strong technical writing, organizational, verbal, and written communication skills.

Preferred Qualifications

• Medical device manufacturing experience.

• Six Sigma or Lean experience.

• ASQ Certified Quality Engineer (CQE) and/or DRM Green Belt Certification.

• Experience with statistical analysis and risk management tools.

Shift

First (Day)

Number of Openings

1

Public Transportation Accessible

No

Veterans Encouraged to Apply

Yes

Physical Required

No

Drug Test Required

Yes

Compensation

$40.00 - $50.00 / Hourly

Postal Code

55430

Job Type

Contract (W2)

Place of Work

On-site

Requisition ID

6758

Job Benefits

Health Insurance, Life Insurance, 401k retirement plan, paid sick time

Application Instructions

If interested and qualified, please submit your resume to View email address on click.appcast.io or visit our website to apply: