Senior Quality Engineer, QMS & Risk Leadership

Medline Industries, Inc.; Northfield (MN); On-site; USD 116,000 - 174,000; Full time

Benefits offered by this job

Health insurance

Life and disability

401(k) contributions

Paid time off

Job summary

Medline Industries, LP in Minnesota seeks an experienced Quality Project Lead to drive quality initiatives across the organization. You will collaborate with cross-functional teams, serve as SME for regulatory compliance, and bridge design with manufacturing to deliver high-quality products.

In this role you will lead risk management activities, manage CAPAs, support cost-saving efforts, and train staff on risk-based decisions.

Qualifications

• Bachelor’s degree in engineering or related science.
• 7+ years of experience in pharmaceutical manufacturing; medical device QA preferred.
• Willingness to travel up to 30% domestically and internationally.

Responsibilities

• Lead project initiatives across quality; present deliverables and train affected groups.
• Identify and drive opportunities to improve the QMS for compliance and efficiency.
• Lead root cause analysis and plan CAPA with timely actions and documentation.
• Evaluate Cost of Quality to identify savings and implement approved projects.
• Provide process guidance across divisions, manufacturing sites, and groups.
• Apply risk management tools (FMEA, fault tree) to mitigate risks with proper documentation.
• Create and deploy risk management processes linked to change control, product release, and investigations.
• Provide training on risk management and risk-based decision making.
• Articulate the risk process and ICH Q9 for regulatory inspections.

Skills

Leadership

Risk management

Quality systems

Cross-functional collaboration

Communication

Analytical thinking

Project management

Education

Bachelor's degree in mechanical engineering, biomedical engineering, electrical engineering, software engineering, or related science

Job description

Medline Industries, LP in Minnesota seeks an experienced Quality Project Lead to drive quality initiatives across the organization. You will collaborate with cross-functional teams, serve as SME for regulatory compliance, and bridge design with manufacturing to deliver high-quality products.

In this role you will lead risk management activities, manage CAPAs, support cost-saving efforts, and train staff on risk-based decisions.