Quality Engineer II

HireTalent; Marlborough; On-site; GBP 80,000 - 100,000; Full time

Job summary

A professional staffing agency is seeking candidates for a quality assurance role focused on test method validation in Marlborough, UK. The position requires a bachelor's degree in Engineering, Quality Assurance, or a related field, along with 3-5 years of relevant experience. Responsibilities include conducting inspections, maintaining compliance with FDA and ISO standards, and assisting in documentation improvements. Candidates must be proficient in technical writing and familiar with validation practices. A 6-month assignment with potential for conversion is offered.

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.

Responsibilities

• Performs inspections and quality assurance testing models for analysis of materials.
• Assists in the review and improvement of test method validation documentation.
• Implements remediation plans to meet regulatory standards.

Skills

Familiar with commonly used concepts in test method validation

Proficiency in technical writing and documentation

Education

Bachelor's degree in Engineering, Quality Assurance, or a related field

Job description

Intake Notes

• Assignment Duration: 6 months
• Shift Hours: 8:30-5pm
• Required Education: Requires a bachelor's degree in Engineering, Quality Assurance, or a related field
• Required # of years’ experience: 3-5
• Conversion possible for the right candidate

Manager Notes

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.

Summary of Duties and 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 0-2 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 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.