Quality Engineer II

Meet Life Sciences; Maple Grove (MN); On-site; USD 70,000 - 90,000; Full time

Job summary

A leading medical equipment firm in Maple Grove is seeking a Quality Engineer to drive quality improvements and manage supplier evaluations. The ideal candidate will possess a BS in engineering and have at least 2 years of experience in quality assurance within regulated industries. Strong problem-solving skills and the ability to develop inspection procedures are essential. This role includes up to 25% travel and offers a contract employment type in a collaborative environment.

Qualifications

• 2+ years of relevant experience in quality improvement.
• Background in regulated industries like medical devices or aerospace.
• Familiarity with CAPA and risk management.

Responsibilities

• Evaluate and qualify suppliers for quality capabilities.
• Develop incoming inspection procedures and train inspectors.
• Analyze material defects and drive corrective actions.

Skills

Evaluation and qualification of suppliers

Strong organizational skills

Communication skills

Project management

Education

BS in engineering or technical field

Tools

PLM

ERP

Job description

Drives quality improvements and corrective actions for components sourced from external suppliers. Supports supplier selection, develops material acceptance criteria, and monitors supplier performance to address yield issues and field failures.

Key Responsibilities:

• Evaluate and qualify new suppliers for technical, quality, and manufacturing capabilities.
• Develop and maintain incoming inspection procedures; train inspectors.
• Identify and implement appropriate inspection tools and equipment.
• Assist in creating and reviewing component specifications.
• Generate test protocols, monitor testing, and approve components for use.
• Support Design Engineering with component selection and reliability analysis.
• Analyze material defects, drive corrective actions, and communicate with suppliers.
• Investigate field failures and implement corrective action plans.

Qualifications:

• BS in engineering or technical field with 2+ years of relevant experience.
• Background in regulated industries (medical device, automotive, aerospace, etc.).
• Familiarity with process validation, design controls, risk management, CAPA, SCAR.
• Strong organizational, communication, and project management skills.
• Able to learn and use software tools (PLM, ERP).
• Up to 25% domestic/international travel.

Preferred Qualifications:

• 3+ years in engineering within regulated industries.
• Experience in problem-solving, auditing (ISO 13485), or quality systems.

Additional Information:

• Works independently, with general supervision.
• Expected to apply judgment in problem-solving and contribute to team objectives.
• Communicates and presents data to internal teams effectively.

Seniority level

• Mid-Senior level

Employment type

• Contract

Job function

• Research

Industries

• Medical Equipment Manufacturing