Sr. Quality Engineer %7C SPT-Waukegan, IL
Company: Medline Industries, Inc.
Posted on: June 22, 2022
JOB SUMMARY: Under minimal supervision, responsible for
independently setting basic quality standards for both in-process
while leading efforts to develop methods for testing, sampling and
training. Evaluate production process, recommend improvements,
qualify and conduct vendor management, generate and maintain
DMR%26rsquo;s, product specifications, design control files, and CE
technical files. MAJOR RESPONSIBILITIES:
- 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 complex 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.
- Direct and collaborate with supplier representatives on quality
problems, ensure that effective corrective actions are implemented
(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.
- 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).
- 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.
- Typically requires a Bachelor%26rsquo;s degree in Engineering,
Science, Math or other related technical field. Work Experience
- At least 4 years of experience in the Quality or
- 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). Knowledge / Skills / Abilities
- Experience developing ways of accomplishing goals with little
or no supervision, depending on oneself to complete objectives, and
determining when escalation 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 systematic
- Experience leading a team to accomplish cross-functional
- Experience using MS Office Suite products (Word, Excel,
PowerPoint, and Outlook).
- Advanced Skill Level in Microsoft Excel (for example: Pivot
tables & pivot reporting, conditional formatting, tables, formulas,
charting) PREFERRED JOB REQUIREMENTS
- 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.
Keywords: Medline Industries, Inc., Waukegan , Sr. Quality Engineer %7C SPT-Waukegan, IL, Engineering , Waukegan, Illinois
Didn't find what you're looking for? Search again!