Quality Engineer

Katalyst CRO; Buffalo Grove (IL); On-site; USD 70,000 - 90,000; Full time

Job summary

Katalyst CRO is seeking a Quality Specialist in Buffalo Grove, Illinois, to provide cross-divisional support for remediation efforts. You'll be responsible for maintaining quality standards across medical device, commodity, OTC drug, and cosmetic products. This involves leading investigations into non-conformances, ensuring compliance with regulations, and conducting product testing. Required experience includes at least 2 years in industry and proficiency with quality assurance standards. Ideal candidates will have strong problem-solving abilities and excel in managing multiple projects.

Qualifications

• Experience developing ways of accomplishing goals with little or no supervision.
• Experience using time management skills to prioritize and organize projects.
• Experience problem solving and reaching positive solutions.

Responsibilities

• Provide Quality expertise in Product Development and Design Control activities.
• Lead investigations of product and process non-conformances.
• Ensure compliance with domestic and international regulations.
• Design and perform experimental product testing to maintain quality levels.

Skills

Quality expertise

Problem-solving skills

Time management

Statistical process control

Intermediate Microsoft Excel

Education

2 years of industry experience in Medical Devices, Drugs

Tools

MS Office Suite

ISO 13485

21 CFR 820

Job description

Summary

Will provide cross-divisional support for remediation efforts. Under broad supervision, responsible for independently setting and upholding quality standards for portfolio of medical device, commodity, OTC drug, and/or cosmetic products. Evaluate production process, recommend improvements, qualify and conduct vendor management, generate and maintain DMR's, product specifications, design control files, and CE technical files.

Roles & Responsibilities

• Provide Quality expertise in Product Development, Design Control activities, Design History Files, CAPA, Risk Management, and CE Technical Files.
• Direct and collaborate with supplier representatives on quality problems, ensure corrective action implementation (CAPA, SCAR), and contribute to supplier quality improvement programs, and lead supplier qualifications.
• Lead investigations of product and process non-conformances and out-of-specification results and develop effective corrective and preventive actions (CAPA).
• 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.
• Manage the development and implementation of methods and procedures for process control, process validation, process improvement, testing, and inspection to ensure that products are ideal and functional.
• Design experiments to understand sources of variation affecting products and processes. Applies statistical process control (SPC) methods for analyzing data to evaluate the current process 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.
• Coordinate product testing with internal and external laboratories as required.
• Responsible for building 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.

Education & Experience

• Experience developing ways of accomplishing goals with little or no supervision, depending on oneself to complete objectives, and determining when escalation of issues is necessary.
• Experience using time management skills to prioritize, organize, and track details in order to meet deadlines of multiple projects.
• Experience problem solving, overcoming obstacles, and reaching a positive and successful solution through mathematical or systematic operations.
• Experience using MS Office Suite products (Word, Excel, PowerPoint, Outlook).
• Intermediate Skill Level in Microsoft Excel (for example: conditional formatting, tables, formulas, charting)
• Working knowledge of government and industry quality assurance codes and standards (e.g. 21 CFR 820, ISO13485).
• Position requires up to 15% travel.
• At least 2 years of industry experience in Medical Devices, Drugs, and/or fields directly related to the role.