Quality Engineer (Med Tech) - ISO 13485 & Validation

Custom Wire Technologies; Port Washington (WI); On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

Medical

Dental

Vision

Life and disability

Paid Time Off

401(k) with company match

Profit Sharing

Paid Holidays

Job summary

Custom Wire Technologies is seeking a Quality Engineer to ensure product compliance with ISO 13485 standards. This role involves developing quality control procedures and leading validation activities. Candidates should have at least 3 years of quality experience in ISO manufacturing.

The position offers a comprehensive benefits package, including medical, dental, and a 401(k) plan with a company match, located in Port Washington, Wisconsin.

Qualifications

• 3+ years related quality experience in ISO manufacturing environment.
• Strong knowledge of validations and qualifications of products and processes.
• ISO 13485 experience preferred.

Responsibilities

• Develop and improve technical procedures related to quality control and product validation.
• Lead validation activities (IQ, OQ, PQ) for equipment and products.
• Analyze quality data and assist in resolving quality issues.

Skills

Attention to detail

Problem-solving skills

Ability to analyze blueprints

Root cause analysis

Education

Bachelor of Science degree - Engineering or related field

Tools

Keyence

Micro Vu

Job description

Custom Wire Technologies is seeking a Quality Engineer to ensure product compliance with ISO 13485 standards. This role involves developing quality control procedures and leading validation activities. Candidates should have at least 3 years of quality experience in ISO manufacturing.

The position offers a comprehensive benefits package, including medical, dental, and a 401(k) plan with a company match, located in Port Washington, Wisconsin.