Engineer Quality

About the Role

Under broad supervision, independently set 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, and generate and maintain 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 quality and functionality standards.
• Design 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 and 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, ensure corrective action implementation (CAPA, SCAR), 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 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., as required.
• Coordinate product testing with internal and external laboratories as needed.
• Ensure compliance with domestic and international regulations associated with product lines and processes. Perform quality reviews of design documentation for compliance with stated requirements, including vendor quality documents and company quality records.
• Lead investigations of product and process non-conformances and out-of-specification results and develop effective corrective and preventive actions (CAPA).

Requirements

• Bachelor’s degree in Engineering, Science, Math, or other related technical field.
• At least 2 years of experience in Quality or Engineering.
• Experience developing ways of accomplishing goals with little or no supervision, determining when escalation of issues is necessary.
• Strong time management skills to prioritize, organize, and track details to meet deadlines of multiple projects.
• Problem-solving skills to overcome obstacles and reach positive, successful solutions through mathematical or systematic operations.
• Proficiency in MS Office Suite (Word, Excel, PowerPoint, Outlook).
• Intermediate skill level in Microsoft Excel (e.g., conditional formatting, tables, formulas, charting).
• Working knowledge of government and industry quality assurance codes and standards (e.g., 21 CFR 820, ISO13485).
• Up to 15% travel required.

Preferred Qualifications

• At least 2 years of industry experience in Medical Devices, Drugs, and/or fields directly related to the role.

Pay

Anticipated salary range: $79,000.00 - $119,000.00 annually. Actual salary will vary based on 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).