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    Jr. NPI Quality Engineer - Manchester, United States - Merrimack Manufacturing

    Merrimack Manufacturing
    Merrimack Manufacturing Manchester, United States

    2 weeks ago

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    Description
    Job Description

    Job Description Merrimack Manufacturing is seeking an

    Jr.


    NPI
    Quality Engineer

    to support 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.

    How you will make an impact:

    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 protocol generation, execution, documentation organization, report writing, etc. while meeting schedule for final approval and release for use
    Lead 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
    Participate in Material Review Board (MRB) meetings, track and follow through with nonconformance reports assigned
    Support and contribute towards the success of external audits, whether conducted by the FDA, a Notified Body, other regulatory bodies, or external customers
    To be successful in this role, you will need the following skills and experience:

    Candidate must have a B.A. or B.S. degree; equivalent experience in relevant technical fields will be considered

    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 and Six Sigma certification strongly preferred
    Strong knowledge of IQ/OQ/PQ requirements, measurement system analysis, and supporting engineering specifications
    Knowledge of New Product Introduction 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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