NPI Quality Engineer

• Leverage your engineering and technical experience to evaluate new products, manufacturing processes and ensure compliance with applicable regulatory standards throughout the New Product Introduction process
• Provide input to the development, review, and update of User Requirements, critical quality attributes, and other design documentation
• Lead project teams through validation protocol generation, execution, documentation organization, report writing, etc. while meeting schedule for final approval and release
• Conduct investigations resulting in root cause and corrective actions through use of data analysis, inductive and deductive reasoning, and problem solving skills
• Lead the evaluation and identification of validation requirements and sampling plans for new, and changes to, manufacturing processes, test methods, and equipment
• Develop inspection procedures and sampling plans for new production, continuous improvement of process controls, and improved workflow/worker satisfaction
• Assist in the development, implementation, and approval of Device Master Records, Device History Records, and Risk Management Files for new products
• Provide guidance and assistance on the assessment of new and changes to existing manufacturing equipment, ensuring proper enrollment into QMS systems and that Validation requirements are met
• Lead improvement projects to increase efficiency and compliance within Merrimack Manufacturing’s Quality Management System
• Contain defective product and processes systemically, participate in Material Review Board (MRB) meetings, track and follow through with nonconformance investigations assigned to internal and external team members.
• Support and contribute towards the success of external audits, whether conducted by the FDA, a Notified Body, other regulatory bodies, or external customers

• At least 3 years of experience in Medical Device Manufacturing or other similarly regulated industry such as Aerospace, Military, etc.
• Strong knowledge of CFR Part 820 and ISO 13485 required
• Lean or Six Sigma certification preferred
• Strong knowledge of IQ/OQ/PQ requirements, measurement system analysis, and supporting engineering specifications
• Knowledge of Design Transfer and introduction of new product processes and deliverables
• Strong knowledge of tolerance stack up calculations and calibration best practices
• Strong organization, communication, and time management skills; Project Management experience preferred
• Knowledge of industry standards and best practices for Software Validation, Controlled Environments, Biocontamination Controls, and Gamma Irradiation also preferred

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