Senior Engineer Quality

About the role

Under minimal supervision, responsible for independently setting basic quality standards for in-process production while leading efforts to develop methods for testing, sampling, and training. Evaluate production processes, recommend improvements, qualify and conduct vendor management, generate and maintain Device Master Records (DMRs), product specifications, design control files, and CE technical files.

Responsibilities

• Manage the development and implementation of methods and procedures for process control, process validation, process improvement, testing, and inspection to ensure products meet functional and quality standards.
• Design complex experiments to understand sources of variation affecting products and processes.
• Apply statistical process control (SPC) methods for analyzing data to evaluate current processes and process changes.
• Design and perform experimental product testing and analysis to maintain quality levels and minimize defects and failure rates.
• Generate and analyze reports on defective products to determine trends and lead corrective actions.
• Use concepts of probability and statistical quality control to guide decisions.
• Direct and collaborate with supplier representatives on quality problems, ensuring effective corrective actions (CAPA, SCAR) and contributing to supplier quality improvement programs. Lead supplier qualifications.
• Provide Quality expertise in Product Development, Design Control activities, Risk Management, and CE Technical Files.
• Build appropriate product documentation (e.g., Device Master Records) in compliance with applicable regulations. Work with Regulatory Groups and Suppliers to produce 510K submissions, letters to file, etc.
• Coordinate product testing with internal and external laboratories as required.
• Ensure compliance with domestic and international regulations associated with product lines and processes. Perform quality reviews of design documentation for compliance, including vendor quality documents and company quality records.
• Lead investigations of product and process non-conformances and out-of-specification results, developing effective corrective and preventive actions (CAPA).
• May train and coach team members and Medline employees on appropriate processes and best practices.
• Act as Quality lead in the absence of Quality Management.

Requirements

• Bachelor’s degree in Engineering, Science, Math, or other related technical field.
• At least 4 years of experience in Quality or Engineering.
• Experience applying knowledge of government and industry quality assurance codes and standards (e.g., 21 CFR 820, ISO13485, 21 CFR 210 and 211, MDD/MDR, and ANSI/AAMI/ISO sterilization standards).
• Experience developing ways of accomplishing goals with little or no supervision, determining when escalation is necessary.
• Experience using time management skills to prioritize, organize, and track details to meet deadlines of multiple projects.
• Experience problem-solving and overcoming obstacles to reach positive and successful solutions through mathematical or systematic operations.
• Experience leading a team to accomplish cross-functional goals.
• Proficiency in MS Office Suite (Word, Excel, PowerPoint, and Outlook).
• Advanced skill level in Microsoft Excel (e.g., pivot tables, pivot reporting, conditional formatting, tables, formulas, charting).
• Position requires up to 15% travel.

Preferred Qualifications

• 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.

Pay

The anticipated salary range for this position is $101,000 - $152,000 annually. The actual salary will vary based on applicant’s location, education, experience, skills, and abilities. This role is bonus and/or incentive eligible.

Benefits

• Health insurance, life and disability coverage.
• 401(k) contributions.
• Paid time off.
• Employee Assistance Program, Employee Resource Groups, and Employee Service Corp (for employees working less than 30 hours per week).