Quality Engineer

Title: Quality Engineer II

Location: Marlborough, MA

Duration: 06 Months

Schedule: Regular Business Hours

Job Description:

• 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.

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.

If you are not interested in looking at new opportunities at this time I fully understand. I would in that case be appreciative of any referrals you could provide from your network of friends and colleagues in the industry. We do offer a referral bonus that I’d be happy to extend to you if they turn out to be a great fit for my client.

Thank you for your time and for your consideration. I look forward to hearing from you.