Senior Quality Engineer - Redmond, OR

Job Summary

About the role

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.

Responsibilities

• Evaluate production process, recommend improvements, qualify and conduct vendor management, generate and maintain DMR’s, product specifications, design control files, and CE technical files.
• 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.
• Cooky/copyright/legal/EEO/scam-warning boilerplate removed.

Requirements

• Education: Bachelor’s degree in Engineering, Science, Math or other related technical field.
• Work Experience: 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).
• Knowledge /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).
• Preferred Qualifications: 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. Medline Industries, LP and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization.
• The Anticipated Salary Range For This Position: $101,000.00 - $152,000.00 Annual. The actual salary will vary based on applicant’s location, education, experience, skills, and abilities.
• Position requires up to 15% travel.

Benefits

• Health insurance
• Life and disability
• 401(k) contributions
• Paid time off
• Employee Assistance Program
• Employee Resource Groups
• Employee Service Corp

Pay

The Anticipated Salary Range For This Position: $101,000.00 - $152,000.00 Annual. The actual salary will vary based on applicant’s location, education, experience, skills, and abilities.

Schedule

Not specified.