Senior Quality Engineer: Process & Compliance Lead

Medline Industries, Inc.; Northfield (MN); On-site; USD 101,000 - 152,000; Full time

Benefits offered by this job

Health insurance

Life and disability

401(k) contributions

Paid time off

Job summary

Medline Industries, LP seeks a Quality Engineer who will independently set basic quality standards for in-process work and lead testing, sampling, and training efforts. You will evaluate production processes, qualify vendors, generate DMRs and design control files, and support CE technical files.

Responsibilities include developing methods for process control, validation, and improvement; designing experiments; applying SPC; and leading CAPA and supplier qualifications while collaborating with

Qualifications

• Bachelor’s degree in Engineering, Science, Math or related technical field.
• At least 4 years in Quality or Engineering.
• Experience with government/industry QA codes (e.g. 21 CFR 820, ISO13485, 21 CFR 210-211, MDD/MDR, ANSI/AAMI/ISO).
• Strong problem solving and leadership in cross-functional teams.
• Up to 15% travel.

Responsibilities

• Develop and implement methods for process control and validation.
• Design experiments and apply SPC to evaluate processes.
• Test and analyze products, generate reports to guide CAPA.
• Lead supplier quality and perform supplier qualifications.
• Create device master records and CE files with regulatory groups.

Skills

Quality engineering

SPC

CAPA

Supplier quality

Regulatory knowledge

MS Excel

Education

Bachelor's degree in Engineering/Science

Tools

Microsoft Excel

Job description

Medline Industries, LP seeks a Quality Engineer who will independently set basic quality standards for in-process work and lead testing, sampling, and training efforts. You will evaluate production processes, qualify vendors, generate DMRs and design control files, and support CE technical files.

Responsibilities include developing methods for process control, validation, and improvement; designing experiments; applying SPC; and leading CAPA and supplier qualifications while collaborating with