Quality Engineer

Quality Engineer

Opportunity to join a growing site of a Global Medical Device Manufacturer. Become a key contributor on the team working directly in-line with Leadership.

About Our Client

My client is a global manufacturer and leading provider of assembly for medical devices. They are backed by over 60+ years of excellence and have over 10 locations worldwide. Three of those locations are located in New England with the site in Torrington anticipating excellent growth over the coming year.

Job Description

The key responsibilities of the Quality Engineer are the following:

• Develop and implement validation master plans, protocols, and reports for equipment, processes, and software.
• Execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for new and existing equipment.
• Ensure validation activities comply with FDA, ISO 13485, and other relevant regulatory requirements.
• Conduct risk assessments using tools such as FMEA (Failure Modes and Effects Analysis) to identify potential hazards and mitigate risks.
• Collaborate with cross-functional teams to develop and implement risk mitigation strategies.
• Identify opportunities for process improvement and implement changes to enhance efficiency and product quality.
• Stay current with industry trends, regulatory changes, and best practices in validation engineering.

Please apply using the link below. Qualified applicants will be contacted within 24-48 hours of submittal and receive full job description for position. MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.

The Successful Applicant

The successful Quality Engineer will have the following:

• Prior experience with validation protocols (IQ, OQ, PQ)
• Root Cause Analysis experience
• Independent time management and communication skills
• Metrology experience- Ideally with Calypso (Zeiss CMM software)
• Minitab experience
• Injection molding exposure

What's on Offer

The client can offer the following:

• Competitive Base Salary
• Bonus Potential
• Terrific Benefits
• Growth opportunities for advancement within the organization