Quality Engineer

Title: Quality Engineer III (3 Openings)

Location: Bethel, CT

Employment Type: Contract (6+ months, with strong potential to extend or convert)

Status: Accepting Candidates

About the Role

We are seeking a Quality Engineer III to support new product and process introductions, risk management, root cause investigations, and equipment, process, and product qualifications and validations within a medical device manufacturing environment.

Key Responsibilities

• Quality Engineering and Process Improvement
• Apply various tools and methods to identify and support new product or process introductions and business improvements.
• Lead and contribute to the development and application of innovative risk management and risk mitigation practices.
• Root Cause Analysis and Corrective Actions
• Lead and contribute to root cause investigations using various problem-solving techniques and tools.
• Assess the effectiveness of corrective actions.
• Testing, Qualification, and Validation
• Lead, conduct, and support the development of test methods for equipment, process, and product qualifications and validations.

Qualifications

• Bachelor’s degree in Engineering or a similar field.
• 2+ years of experience in a Quality Engineering role within a medical device manufacturer or start-up company, or equivalent engineering experience.
• Familiarity with ISO 13485 standards and FDA 21 CFR 820 regulations.
• Proven experience creating job-related documentation for quality purposes.

Compensation

• Pay Rate: $45–$50/hour
• Location: Bethel, CT
• Duration: 6+ months, with strong potential to extend or convert