Medline Industries, LP · 1 hour ago
Senior Quality Engineer - Redmond, OR
Redmond, Oregon
Full-time
Onsite
Mid, Senior Level
$92K/yr - $138K/yr
4+ years expMedline Industries, LP is a leading provider in the medical supply industry, and they are seeking a Senior Quality Engineer to ensure product quality and compliance with regulations. The role involves managing quality standards, leading process improvement initiatives, and collaborating with suppliers to enhance product quality.
Consumer GoodsHealth CareHospitalityManufacturingMedical
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 quality records
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
Qualification
Required
Bachelor's degree in Engineering, Science, Math or other related technical field
At least 4 years of experience in the 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, 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 projects
Experience problem solving, overcoming obstacles and reaching a positive and successful solution through mathematical or systematic operations
Experience leading a team to accomplish cross-functional goals
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)
Position requires up to 15% travel
Preferred
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
Benefits
Health insurance
Life and disability
401(k) contributions
Paid time off
Company
Medline Industries, LP
Medline is the largest provider of medical-surgical products and supply chain solutions serving all points of care.
10001+ employees
H1B Sponsorship
Medline Industries, LP has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (344)
2024 (144)
2023 (142)
2022 (143)
2021 (137)
2020 (113)
Funding
Current Stage
Public CompanyTotal Funding
$0.5MKey Investors
North Carolina Department of Commerce
2025-12-17IPO
2021-06-05Private Equity
2019-09-12Grant· $0.5M
Leadership Team
Steve Miller
Chief Operating Officer
Amanda Laabs
Chief Product Officer
Recent News
2025-12-26
TheStreet.com
2025-12-20
2025-12-19
Company data provided by crunchbase