Quality Engineer II – Medical Devices, Onsite

Experis; Saint Paul (MN); On-site; USD 32,000 - 52,000; Full time

Job summary

Experis is seeking a Development Quality Engineer II in Saint Paul, MN for a 12-month, onsite role. Compensation ranges from $35 to $38 per hour on W2.

The role focuses on leading quality disciplines, design control deliverables, and risk management across PDP/CPDP projects, with heavy emphasis on regulatory compliance and device manufacturing support. The candidate will contribute to plan development, verification and validation activities, issue essential output reports, and maintain DHF

Qualifications

• Bachelor degree in engineering or technical field.
• 2-5 years of R&D, process/manufacturing engineering, or quality.
• Experience in medical devices and related regulations/standards.
• Process validation planning and execution experience.
• Inspection or test method validation experience.

Responsibilities

• Participate in or lead teams in supporting quality disciplines, decisions, and practices.
• Lead on-time completions of design control deliverables.
• Support on-time execution of Quality Plans for PDP, CPDP and design change projects.
• Gen­eration of process validation test plans/reports.
• Gen­eration of PDP design verification test plans/reports for product requirements.
• Lead or support risk management activities from concept through commercialization.
• Identify essential outputs and generate Essential Output reports.
• Complete labeling verification activities and reports.
• Collaborate with process engineering on manufacturing and validation deliverables.
• Ensure DHF content integrity and regulatory compliance.
• Support device manufacturing activities from concept to commercialization.

Skills

Quality engineering

Design control

Risk management

Validation & Verification (V&V)

Regulatory compliance

Education

Bachelor's degree in engineering or technical field

2-5 years of R&D/Process/Manufacturing Engineering or Quality

Tools

FMEA

CAPA

GMP

Job description

Experis is seeking a Development Quality Engineer II in Saint Paul, MN for a 12-month, onsite role. Compensation ranges from $35 to $38 per hour on W2.

The role focuses on leading quality disciplines, design control deliverables, and risk management across PDP/CPDP projects, with heavy emphasis on regulatory compliance and device manufacturing support. The candidate will contribute to plan development, verification and validation activities, issue essential output reports, and maintain DHF