Quality Engineer II

SGS Consulting; Boston (MA); Sur place; USD 65 000 - 90 000; Plein temps

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Test method validation

Regulatory compliance

Technical writing

Documentation

Quality inspection

Formation

Bachelor’s degree in Engineering or QA

Description du poste

Job Responsibilities

Performs inspections and sets quality assurance testing models for analysis of raw materials, materials in process, and finished products. Requires a bachelor's degree and 02 years of experience in the field or in a related area. Has knowledge of commonly used concepts, practices, and procedures within a particular field. Relies on instructions and preestablished guidelines to perform the functions of the job. Works under immediate supervision. Primary job functions do not typically require exercising independent judgment. Typically reports to a supervisor or manager.

Skills

Assists in the review and improvement of existing test method validation documentation. Supports Test Method Validation Remediation. Implements remediation plans to ensure test methods comply with current regulatory standards. Ensures validation documents meet FDA, ISO 13485, and other relevant regulatory requirements. Maintains accurate and organized records of validation activities. Familiar with commonly used concepts, practices, and procedures in test method validation. Proficiency in technical writing and documentation. Relies on instructions and pre-established guidelines to perform job functions. Works under immediate supervision, with primary job functions not typically requiring independent judgment. Reports to a supervisor or manager.

Education/Experience

Requires a bachelor’s degree in engineering, Quality Assurance, or a related field. Required # of years’ experience: 3 - 5 years