Company: Katalyst Healthcares & Life Sciences
Posted on: November 19, 2022
- 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
- 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
- Provide Quality expertise in Product Development, Design
Control activities, Risk Management, and CE Technical
- 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.
- 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 with stated
requirements, including vendor quality documents and company
- Lead investigations of product and process non-conformances and
out-of-specification results and develop effective corrective and
preventive actions (CAPA).
- Typically requires a Bachelor's degree in Engineering, Science,
Math or other related technical field.
- At least 2 years of experience in the Quality or
- 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
- Experience problem solving, overcoming obstacles, and reaching
a positive and successful solution through mathematical or
- 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).
- At least 2 years of industry experience in Medical Devices,
Drugs, and/or fields directly related to the role
Keywords: Katalyst Healthcares & Life Sciences, Arlington Heights , Quality Engineer, Engineering , Mundelein, Illinois
Didn't find what you're looking for? Search again!