Quality Engineer II

ZipRecruiter; City Of London; On-site; GBP 80,000 - 100,000; Full time

Job summary

A distinguished staffing company is seeking a Quality Engineer II to perform quality assurance testing and inspections. The ideal candidate should have a bachelor's degree in engineering or Quality Assurance with 3-5 years of experience in test method validation. This role is onsite and involves ensuring compliance with regulatory standards while supporting documentation processes.

Qualifications

• 3-5 years of experience in test method validation or a related area.
• Familiarity with FDA, ISO 13485, and related regulatory requirements.

Responsibilities

• Perform inspections and set quality assurance testing models.
• Ensure validation documents meet all regulatory requirements.
• Assist in the review and improvement of existing test method validation documentation.

Skills

Test method validation

Technical writing

Quality assurance practices

Education

Bachelor’s degree in engineering or Quality Assurance

Job description

Job Title

Quality Engineer II

Work Site

Marlborough, MA 01752 – Onsite

Duration

06 Months Contract with possible extension

Conversion possible for the right candidate

Shift/Schedule

8:30-5pm

Job Description

• Performs inspections and sets quality assurance testing models for analysis of raw materials, materials in process, and finished products.
• Has knowledge of commonly used concepts, practices, and procedures within a particular field.
• Relies on instructions and pre-established 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.
• Supports Test Method Validation Remediation.
• Assists in the review and improvement of existing test method validation documentation.
• Implements remediation plans to ensure test methods comply with current regulatory standards.

Documentation and Compliance

• Ensures validation documents meet FDA, ISO 13485, and other relevant regulatory requirements.
• Maintains accurate and organized records of validation activities.

Qualifications

• Requires a bachelor’s degree in engineering, Quality Assurance, or a related field.
• 3-5 years of experience in test method validation or a related area.

Knowledge and Skills

• Familiar with commonly used concepts, practices, and procedures in test method validation.
• Proficiency in technical writing and documentation.

Work Guidelines

• 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.

Company Description

Source International (SSI) is a distinguished staffing company with nearly 25 years of experience, renowned for delivering top-tier workforce solutions encompassing staffing, recruiting, and managed services. As a proud supplier, we bring a wealth of expertise and best-in-business differentiators to comprehensively support your diverse workforce needs. Based in Minneapolis, Minnesota, USA, SSI has established itself as a global leader, serving a broad clientele across industries with unwavering dedication and excellence. SSI is ISO 9001, 14001, and Soc2 Type2 certified, underscoring our commitment to quality and security. We have garnered numerous sustainability and supplier awards, further validating our industry-leading capabilities.