Quality Engineer II - Medical Devices | CAPA/QMS Specialist

Arch-Medical-Solutions; Kenosha (WI); On-site; USD 70,000 - 90,000; Full time

Job summary

Arch-Medical-Solutions is seeking a Quality Engineer in Kenosha, Wisconsin. The candidate will lead quality programs to ensure compliance with FDA and ISO standards, oversee audits, and address customer complaints. A Bachelor’s degree in a related field and 5-7 years of experience in medical device manufacturing are required.

The role emphasizes strong problem-solving skills, as well as effective communication. Knowledge of CNC machining and quality regulations is preferred.

Qualifications

• 5-7 years of experience in the medical device manufacturing industry.
• Knowledge of FDA and ISO regulations.
• Experience in quality engineering or equivalent.

Responsibilities

• Lead quality control programs to meet FDA and ISO standards.
• Investigate and address customer complaints.
• Assist in internal/external audits of the QMS.

Skills

Quality Engineering

CNC Machining

ISO 13485 Knowledge

Geometric Dimensioning and Tolerancing

Communication Skills

Problem Solving

Education

Bachelor’s degree in Quality Engineering or related field

Tools

Microsoft Office

EPICOR

Job description

Arch-Medical-Solutions is seeking a Quality Engineer in Kenosha, Wisconsin. The candidate will lead quality programs to ensure compliance with FDA and ISO standards, oversee audits, and address customer complaints. A Bachelor’s degree in a related field and 5-7 years of experience in medical device manufacturing are required.

The role emphasizes strong problem-solving skills, as well as effective communication. Knowledge of CNC machining and quality regulations is preferred.