Quality Engineer- Medical Device- Dover NH

The Quality Engineer supports the Quality Management System (QMS) to ensure compliance with regulatory and procedural requirements in the manufacturing of disposable medical products. They assist the assigned Value Stream Business Unit in implementing programs to control processes and products, ensuring alignment with established quality standards.

Client Details

The company specializes in providing high-quality manufacturing solutions for the medical device industry, particularly in disposable medical products. They offer end-to-end services, including design, development, and manufacturing, ensuring compliance with regulatory standards and maintaining exceptional quality throughout production. Their expertise spans various aspects of medical product development, focusing on innovation, reliability, and efficiency.

Description

Responsibilities:

• Ensure adherence to ISO 13485:2016, 21 CFR 820, MDD, and internal Quality Management System standards.
• Serve as the key quality liaison for assigned customers and suppliers.
• Track and analyze customer complaints and trends, leading investigations and implementing corrective actions.
• Lead quality support for existing product/process challenges, including NCMRs, MRBs, root cause analysis, deviations, and test protocols.
• Conduct comprehensive risk assessments for product and process transfers following ISO 14971 guidelines.
• Develop and manage Quality Plans and Master Validation Plans for smooth customer product transitions.
• Design and oversee verification/validation protocols for seamless implementation in a clean room production environment.
• Manage customer deliverables and ensure timely approval and release of quality documentation.
• Actively engage in customer business reviews, presenting key performance metrics.
• Support Notified Body and customer audits, and conduct audits of suppliers as necessary.
• Investigate and resolve internal, customer, and supplier quality issues with a focus on continuous improvement.
• Partner with Engineering and Manufacturing teams to establish robust process controls and product capabilities.
• Spearhead root cause failure analysis for product, process, and component issues with cross-functional teams.
• Drive the CAPA process to completion, ensuring thorough corrective and preventive actions are implemented.
• Evaluate and approve proposed changes to the Quality Management System, validations, and deviations.

Profile

Qualifications:

• In-depth knowledge of ISO 13485:2016 and FDA QSR (21 CFR Sec. 820) for medical device production.
• Familiarity with EEC Medical Device Directives and relevant product-specific standards.
• Strong expertise in ISO 14971 for Risk and Hazard Assessment.
• Proficient in statistical analysis with Minitab software for data interpretation.
• Skilled in Root Cause Analysis using tools like Fishbone Diagrams and Fault Tree Analysis.
• Excellent written and verbal communication skills.
• Competent in Microsoft Office Suite, including Word, Excel, PowerPoint, and Visio.
• Strong presentation and training capabilities.

Job Offer

• Competitive Compensation: Salary based on experience.
• Comprehensive Benefits: Health, vision, dental, 401(k), disability.
• Work-Life Balance
• Career Development
• Challenging Projects: Work on high-impact medical device projects.
• Collaborative Environment: Team-oriented, knowledge-sharing culture.
• Compliance Leadership: Lead regulatory compliance and quality initiatives.
• Personal Growth: Gain experience in ISO 13485, FDA QSR, and process improvement.

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.