NPI Quality Engineer

NPI Quality EngineerPosition Overview: This position supports design transfer activities and quality operations in an innovative, fast-paced, medical device-manufacturing environment. This role includes generation and maintenance of control plans, risk management files, validation protocols, and other QMS documentation to support initial qualification and launch of commercial production activity. The role will also provide support to the organizational goals by leading improvement projects to increase efficiency and compliance across the site.Responsibilities:

• 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 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

Qualifications and Skills:

• 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

Education: B.A. or B.S. degree; equivalent experience in relevant technical fields will be considered