Quality Engineer II – Medical Devices & Compliance

LKC Technologies; Germantown (MD); On-site; USD 75,000 - 95,000; Full time

Job summary

A leader in eye testing solutions seeks a Quality Engineer II in Germantown, MD. This full-time role involves developing quality control strategies and ensuring compliance with industry standards, primarily ISO 13485. Ideal candidates have a Bachelor's degree in a relevant field and at least 3 years of experience in a quality engineering role. Responsibilities include managing quality processes, performing inspections, and evaluating changes for quality impacts. Strong communication and problem-solving skills are essential for success in this position.

Qualifications

• Minimum 3 years’ experience in a quality engineering role in the medical or electronics industry.
• Proficient in Quality Control and Quality Assurance principles.
• Detail-oriented with strong problem-solving skills.

Responsibilities

• Implement and maintain quality systems compliant with ISO 13485.
• Conduct final QC tests and approvals for finished goods.
• Manage supplier quality and perform audits as needed.

Skills

Quality Engineering practices

Analytical skills

Problem-solving skills

Communication abilities

Collaboration skills

Education

Bachelor’s degree in Scientific, Engineering, or Quality Management

Tools

ISO 13485

CAPA

DFMEA

PFMEA

Job description

A leader in eye testing solutions seeks a Quality Engineer II in Germantown, MD. This full-time role involves developing quality control strategies and ensuring compliance with industry standards, primarily ISO 13485. Ideal candidates have a Bachelor's degree in a relevant field and at least 3 years of experience in a quality engineering role. Responsibilities include managing quality processes, performing inspections, and evaluating changes for quality impacts. Strong communication and problem-solving skills are essential for success in this position.