Quality Assurance Engineer II - Validation & Compliance

SGS Consulting; Boston (MA); On-site; USD 65,000 - 90,000; Full time

Job summary

SGS Consulting is seeking a Quality Assurance professional to perform inspections and develop testing models for raw materials, in-process materials, and finished products. This role requires a bachelor’s degree and 3–5 years of experience, with guidance provided by supervisors.

Responsibilities include ensuring test method validation aligns with FDA/ISO 13485 standards, maintaining meticulous validation records, and supporting remediation plans under established guidelines.

Qualifications

• Experience with test method validation and remediation.
• Familiar with FDA and ISO 13485 requirements.
• Proficient in maintaining validation records and documentation.

Responsibilities

• Performs inspections and develops quality assurance testing models for analysis of raw materials, in-process materials, and finished products.
• Follows instructions and pre-established guidelines under supervision.
• Maintains accurate records and reports to supervisor or manager.

Skills

Test method validation

Regulatory compliance

Technical writing

Documentation

Quality inspection

Education

Bachelor’s degree in Engineering or QA

Job description

SGS Consulting is seeking a Quality Assurance professional to perform inspections and develop testing models for raw materials, in-process materials, and finished products. This role requires a bachelor’s degree and 3–5 years of experience, with guidance provided by supervisors.

Responsibilities include ensuring test method validation aligns with FDA/ISO 13485 standards, maintaining meticulous validation records, and supporting remediation plans under established guidelines.