Senior Quality Engineer - Medical Devices & CAPA Leader

Medline Industries, LP; Northfield (CT); On-site; USD 101,000 - 152,000; Full time

Benefits offered by this job

Health insurance

401(k) contributions

Paid time off

Job summary

Medline Industries, LP is seeking a quality-focused professional to establish basic quality standards for in-process control, develop testing methods, and manage documentation across CE files and 510K activities. You will lead process validation, supplier quality, CAPA, and design control, collaborating with Regulatory and Lab teams to ensure compliance and product excellence.

Travel up to 15% may be required; a Bachelor’s degree in an engineering or related field and at least 4 years in

Qualifications

• Typically requires a Bachelor’s degree in Engineering, Science, Math or other related technical field.
• Experience applying government and industry quality assurance codes and standards (e.g. 21 CFR 820, ISO13485, 21 CFR 210 and 211, MDD/MDR, ANSI/AAMI/ISO sterilization standards).
• Experience developing ways of accomplishing goals with little or no supervision.

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; apply SPC methods.
• Lead supplier qualifications and collaborate with supplier representatives on quality problems.
• Provide Quality expertise in Product Development, Design Control activities, Risk Management, and CE Technical Files.

Skills

Quality engineering

SPC

CAPA

Vendor management

Design Control

Regulatory knowledge

MS Office

Advanced Excel

Time management

Team leadership

Education

Bachelor’s degree in Engineering, Science, Math or related technical field

Tools

Microsoft Excel

Job description

Medline Industries, LP is seeking a quality-focused professional to establish basic quality standards for in-process control, develop testing methods, and manage documentation across CE files and 510K activities. You will lead process validation, supplier quality, CAPA, and design control, collaborating with Regulatory and Lab teams to ensure compliance and product excellence.

Travel up to 15% may be required; a Bachelor’s degree in an engineering or related field and at least 4 years in