Quality Engineer II: Device Development & Validation

ManpowerGroup Global, Inc.; Saint Paul (MN); On-site; USD 48,216 - 52,348; Full time

Job summary

ManpowerGroup Global, Inc. is seeking a Development Quality Engineer II to join our Fortune 500 client in St. Paul, MN. This on-site role focuses on quality disciplines, design control deliverables, and risk management throughout PDP/CPDP and product development.

The candidate will lead validation planning, DHF integrity, and regulatory compliance, collaborating with design and process engineering to ensure robust manufacturing and documentation. 12-month duration with pay range $35–$38/hr on W2.

Qualifications

• Bachelor's degree in Engineering or other technical field.
• 2–5 years of experience in R&D, Process/Manufacturing Engineering, and/or Quality with at least 1 year direct quality manufacturing support experience.
• Experience in medical devices and associated regulations/standards.
• Experience in process validation planning and execution.
• Experience in inspection method validation or test method validation.

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
• Accountable for generation of process validation test plans/reports
• Accountable for generation of PDP design verification test plans/reports for product/system requirements
• Lead or support Risk Management activities from concept through commercialization, including risk plans/reports, hazard analysis, FMEAs, and Cybersecurity risk assessments
• Lead identification of essential outputs and generate Essential Output reports
• Complete labeling verification activities and reports
• Collaborate with process engineering on manufacturing and validation deliverables
• Collaborate with design engineering on customer/system/product requirements and verification/validation
• Ensure DHF content completion, integrity, and regulatory compliance
• Support device manufacturing activities from concept to commercialization
• Resolve gaps through collaborative communication
• Complete change request reviews promptly and objectively
• Identify and implement effective process control systems for development, qualification and manufacturing
• Assist in CAPA systems to meet internal and external requirements
• Assist in tech development and streamlined business systems to resolve quality issues
• Apply systematic problem solving to identify and resolve quality issues
• Support QMS/EMS and regulatory initiatives
• Maintain regular on-site attendance
• Additional duties may be assigned by management

Skills

Quality Assurance

Regulatory Compliance

Risk Management

Problem Solving

Team Collaboration

Education

Bachelor's degree in Engineering

Tools

CAPA systems

Documentation control tools

Job description

ManpowerGroup Global, Inc. is seeking a Development Quality Engineer II to join our Fortune 500 client in St. Paul, MN. This on-site role focuses on quality disciplines, design control deliverables, and risk management throughout PDP/CPDP and product development.

The candidate will lead validation planning, DHF integrity, and regulatory compliance, collaborating with design and process engineering to ensure robust manufacturing and documentation. 12-month duration with pay range $35–$38/hr on W2.