Senior Manufacturing Quality Engineer - Hartland, WI

Medline Industries, LP • Hartland, WI

2d • $101,000 - $152,000

About The Position

Under minimal supervision, the Senior Manufacturing Quality Engineer independently establishes basic quality standards for in-process operations and leads development of 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 position manages methods and procedures for process control, validation, improvement, testing, and inspection. It uses experimental design and statistical process control to understand process variation, assess changes, maintain product quality, and reduce defects and failures. The engineer leads product and process nonconformance investigations and corrective and preventive actions, collaborates with suppliers on quality issues and qualifications, and provides quality expertise across product development, design control, risk management, regulatory documentation, and product testing.

The role ensures compliance with domestic and international regulations applicable to product lines and processes, reviews design and quality documentation, and works with regulatory groups and suppliers on submissions and related documentation. It may include training and coaching team members and serving 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 accomplish goals with little or no supervision, complete objectives independently, and determine when escalation is necessary.
• Time-management skills to prioritize, organize, and track details while meeting deadlines across multiple projects.
• Problem-solving experience using mathematical or systematic operations to overcome obstacles and reach successful solutions.
• Experience leading a team to accomplish cross-functional goals.
• Experience using Microsoft Office Suite, 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, and/or fields directly related to the role.
• Knowledge of advanced Six Sigma/Lean concepts.

Responsibilities

• Manage development and implementation of methods and procedures for process control, validation, 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 changes.
• Design and perform 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; use probability and statistical quality control concepts to guide decisions.
• Collaborate with supplier representatives to resolve quality problems, implement corrective actions such as CAPA and SCAR, support supplier quality improvement programs, and lead supplier qualifications.
• Provide Quality expertise in product development, design control, 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 other required documentation.
• Coordinate product testing with internal and external laboratories as required.
• Ensure compliance with domestic and international regulations associated with 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.
• May train and coach team members and Medline employees on processes and best practices.
• Act as Quality lead in the absence of Quality Management.
• Travel up to 15%.

Benefits

• Health insurance
• Life insurance
• Disability insurance
• 401(k) contributions
• Paid time off
• Continuing education and training
• Employee Assistance Program, Employee Resource Groups, and Employee Service Corp. access for employees working less than 30 hours per week on average

What This Job Offers

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