Quality Engineer-Medical Device-Winchester, CT
About Our Client
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.
Job 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.
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:
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
What's on 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.