Senior Manufacturing Quality Engineer - Hartland, WI

Medline • Hartland, WI

8h

About The Position

Under minimal supervision, the Senior Manufacturing Quality Engineer independently sets basic quality standards for in-process production and leads efforts to develop testing, sampling, and training methods. The role evaluates production processes, recommends improvements, qualifies and manages vendors, and generates and maintains Device Master Records (DMRs), product specifications, design control files, and CE technical files.

The engineer manages quality-control and process-validation methods, designs experiments and product testing, analyzes data using statistical process control and statistical quality-control concepts, and leads responses to defects, nonconformances, and out-of-specification results. The role also supports product development, design control, risk management, regulatory submissions, supplier quality, and compliance with domestic and international requirements. It may include training and coaching team members and acting as the Quality lead when Quality Management is absent. The position requires up to 15% travel.

Requirements

• Bachelor’s degree in Engineering, Science, Math, or another related technical field.
• At least 4 years of experience in Quality or Engineering.
• Experience applying government and industry quality assurance codes and standards, such as 21 CFR 820, ISO 13485, 21 CFR 210 and 211, MDD/MDR, and ANSI/AAMI/ISO sterilization standards.
• Ability to develop ways to accomplish goals with little or no supervision, work independently toward objectives, and determine when escalation is necessary.
• Time-management skills to prioritize, organize, and track details while meeting deadlines across multiple projects.
• Problem-solving ability, including overcoming obstacles and reaching successful solutions through mathematical or systematic operations.
• Experience leading a team to accomplish cross-functional goals.
• Experience using Microsoft Office Suite products, including Word, Excel, PowerPoint, and Outlook.
• Advanced Microsoft Excel skills, such as pivot tables and reporting, conditional formatting, tables, formulas, and charting.
• Ability to travel up to 15%.

Nice To Haves

• At least 5 years of industry experience in medical devices, drugs, or fields directly related to the role.
• Knowledge of advanced Six Sigma and Lean concepts.

Responsibilities

• Manage development and implementation of methods and procedures for process control, process validation, process improvement, testing, and inspection.
• Design complex experiments to identify sources of variation affecting products and processes.
• Apply statistical process control methods to analyze data and evaluate processes and process changes.
• Design and conduct experimental product testing and analysis to maintain quality and minimize defects and failures.
• Generate and analyze reports and defective products to identify trends and lead corrective actions.
• Apply probability and statistical quality-control concepts to guide decisions.
• Work with supplier representatives to resolve quality problems, ensure effective CAPA and SCAR actions, and contribute to supplier quality improvement programs.
• Lead supplier qualifications.
• Provide Quality expertise in product development, design control activities, risk management, and CE technical files.
• Build product documentation, including Device Master Records, in compliance with applicable regulations.
• Work with Regulatory Groups and suppliers on 510K submissions, letters to file, and related materials as required.
• Coordinate product testing with internal and external laboratories as required.
• Ensure compliance with domestic and international regulations applicable to product lines and processes.
• Review design documentation, vendor quality documents, and company quality records for compliance with stated requirements.
• Lead investigations of product and process nonconformances and out-of-specification results and develop effective corrective and preventive actions.
• Train and coach team members and Medline employees on processes and best practices, as needed.
• Act as Quality lead in the absence of Quality Management.

Benefits

• Competitive total rewards package.
• Continuing education and training.
• Health insurance for employees working 30 or more hours per week on average.
• Life insurance for employees working 30 or more hours per week on average.
• Disability coverage for employees working 30 or more hours per week on average.
• 401(k) contributions.
• Paid time off.
• For employees working less than 30 hours per week, access to the Employee Assistance Program, Employee Resource Groups, and Employee Service Corp.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior