Senior Quality Engineer

Meet Life Sciences Ltd.; United States; Remote; USD 120,000 - 155,000; Part time

Job summary

Meet Life Sciences Ltd. is seeking a Senior Quality Engineer to own and elevate the Quality Management System for our medical device operations.

This remote US-based contract role focuses on ensuring ISO 13485 alignment, FDA requirements, and robust CAPA processes across design, development, and manufacturing. The ideal candidate has 5+ years in medical device quality engineering, familiar with risk management, V&V, and audits, and thrives in a small or growing device environment.

Qualifications

• Bachelor's degree in Engineering, Quality, or a related technical field.
• 5+ years of medical device quality engineering experience.
• Strong knowledge of ISO 13485 and FDA Quality System requirements.
• Experience with CAPA, nonconformances, root cause analysis, and audits.
• Experience with Design Controls, risk management, and V&V.
• Familiarity with ISO 14971.
• Strong communication, documentation, and problem-solving skills.
• Comfortable working independently in a small or growing medical device environment.

Responsibilities

• Support and maintain the Quality Management System in accordance with ISO 13485, FDA requirements, and 21 CFR Part 820/QMSR.
• Support Design Controls, risk management, verification and validation, and design changes.
• Lead and support CAPA, nonconformances, deviations, and root cause investigations.
• Support internal, supplier, and external quality audits.
• Partner with Engineering, Manufacturing, and Regulatory teams to resolve quality issues and improve processes.
• Support supplier quality activities and manufacturing quality initiatives.
• Develop and maintain quality procedures, work instructions, and controlled documentation.
• Monitor quality data and identify opportunities for continuous improvement.

Skills

Quality engineering

Regulatory compliance

CAPA & root cause analysis

Design Controls

Risk management

V&V

ISO 14971

Education

Bachelor's degree in Engineering or related field

Job description

Senior Quality Engineer | Medical Device

Location: Remote, US Based

Employment Type: Contract

Industry: Medical Device

About the Opportunity

We are partnering with a growing medical device company that is looking to add a Senior Quality Engineer to their team. This is a hands-on opportunity within a small organization where the individual will have meaningful ownership across quality systems, product development, and manufacturing.

The ideal candidate will have small/start-up experience in the medical device industry.

Responsibilities

• Support and maintain the Quality Management System in accordance with ISO 13485, FDA requirements, and 21 CFR Part 820/QMSR.
• Support Design Controls, risk management, verification and validation, and design changes.
• Lead and support CAPA, nonconformances, deviations, and root cause investigations.
• Support internal, supplier, and external quality audits.
• Partner with Engineering, Manufacturing, and Regulatory teams to resolve quality issues and improve processes.
• Support supplier quality activities and manufacturing quality initiatives.
• Develop and maintain quality procedures, work instructions, and controlled documentation.
• Monitor quality data and identify opportunities for continuous improvement.

Qualifications

• Bachelor's degree in Engineering, Quality, or a related technical field.
• 5+ years of medical device quality engineering experience.
• Strong knowledge of ISO 13485 and FDA Quality System requirements.
• Experience with CAPA, nonconformances, root cause analysis, and audits.
• Experience with Design Controls, risk management, and V&V.
• Familiarity with ISO 14971.
• Strong communication, documentation, and problem-solving skills.
• Comfortable working independently in a small or growing medical device environment.