Senior Quality Engineer: Process & CAPA Lead

Medline Industries; United States; 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 is seeking a Quality Engineering lead to set fundamental quality standards and guide development of testing, sampling, and training methods across in-process and finished products.

You will design complex experiments, apply SPC, and lead CAPA with suppliers while coordinating with Regulatory to develop 510K submissions and design control files. A strong background in medical device quality standards and cross-functional leadership is essential.

Qualifications

• Bachelor’s degree in Engineering, Science, Math or related technical field.
• At least 4 years in Quality or Engineering.
• Experience with government and industry QA codes and standards (e.g. 21 CFR 820, ISO13485, 21 CFR 210/211, MDD/MDR, ANSI/AAMI/ISO).
• Knowledge of Six Sigma/Lean concepts.

Responsibilities

• Develop and implement methods for process control, validation, improvement and inspection to ensure product quality.
• Design experiments and apply SPC to analyze variation and guide process changes.
• Lead investigations of non-conformances and implement CAPA actions.
• Coordinate with suppliers on quality issues and lead supplier qualifications.
• Prepare and maintain design controls, DMRs and CE/510K documentation with regulatory groups.

Skills

SPC analysis

Time management

Problem solving

Team leadership

Advanced Excel

Education

Bachelor’s degree in Engineering/Science/Math

Tools

MS Office Suite

Job description

Medline Industries is seeking a Quality Engineering lead to set fundamental quality standards and guide development of testing, sampling, and training methods across in-process and finished products.

You will design complex experiments, apply SPC, and lead CAPA with suppliers while coordinating with Regulatory to develop 510K submissions and design control files. A strong background in medical device quality standards and cross-functional leadership is essential.