Quality Engineer - Medical Device - Harwinton, CT

We are seeking a skilled Quality Manufacturing Engineer to join our team. The ideal candidate will have a strong background in quality engineering within the medical device industry, particularly in the realm of injected molded components. This role will focus on ensuring that our manufacturing processes adhere to regulatory standards while optimizing efficiency and maintaining exceptional product quality.

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 this site anticipating excellent growth over the coming year.

Description

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

• Develop and implement quality assurance strategies and processes for injected molded medical device components.
• Collaborate closely with production teams to ensure adherence to quality standards and regulatory requirements (FDA, ISO, etc.).
• Conduct root cause analysis and implement corrective and preventive actions (CAPA) to address non-conformances and quality issues.
• Perform process validation and qualification activities for new and existing manufacturing processes.
• Drive continuous improvement initiatives to enhance manufacturing efficiency and product quality.
• Support supplier quality management activities, including audits and qualifications of suppliers.
• Provide technical support and guidance to cross-functional teams on quality-related matters.
• Participate in internal and external audits, ensuring compliance with regulatory requirements and standards.
• Generate and maintain quality documentation, including quality plans, inspection procedures, and validation protocols.

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

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.