NPI Quality Engineer

My client is looking for a Lead Quality Engineer to join their growing site in Torrington. This professional will be responsible for a variety of tasks including tooling and component inspection, quality improvement, and gauging instruments. The main focus will be to assure that all products meet all customer requirements.

Client Details

My client is 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.

Description

The key responsibilities of the Lead Quality Engineer are the following:

Validation Protocol Development and Execution

• 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.

Risk Assessment and Management

• 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.

Continuous Improvement:

• 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. Profile

The successful Lead Quality Engineer will have the following:

Required:

• Prior experience with validation protocols (IQ, OQ, PQ)
  
• Root Cause Analysis experience
  
• Independent time management and communication skills

Highly Desirable:

• Metrology experience- Ideally with Calypso (Zeiss CMM software)
• Minitab experience
• Injection molding exposure

Job Offer

The client can offer the following:

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

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.