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    Sr. Quality Engineer - San Jose, United States - Noah Medical

    Noah Medical
    Noah Medical San Jose, United States

    3 weeks ago

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    Description
    About The Team:

    The Manufacturing Quality Engineer reports to the Manufacturing Quality Engineering Lead or equivalent manager.

    This position provides hands-on guidance and leadership from a Quality and Regulatory perspective to the team throughout the product development cycle, especially with V&V and Design Transfer stages.

    The focus is to provide engineering support so high-quality products can be produced in a world class manufacturing infrastructure.

    We are looking for someone that is highly motivated in their career growth, a self-starter, a team builder, and an excellent communicator.


    The role will collaborate closely with cross-functional teams to ensure efficient manufacturing operations, optimize production schedules, meet customer demands, improve processes, support NPI, scale production, improve the factory, own safety and facilities, while maintaining high-quality standards.

    A Day In The Life Of Our Sr. Quality Engineer

    :

    Develop and support Product Final Acceptance processes.

    Engage in procedure validation and improvement activities.

    Provide hands-on leadership and guidance to Design Transfer requirements, Risk Management, Manufacturing processes, incoming and in-process inspection, test methods/specifications, Process

    Validation (including sterilization), and finished product release activities.

    Participate in new product development teams and represent Quality function as needed. Provide relevant input to the product development planning process according to project milestones and

    QMS implementation /requirements/trace matrix.


    Define, implement, and provide training on relevant aspects of Noah Medical's Quality Management System to meet US FDA and International requirements.

    Grow in QE/QMS expertise as defined by the manager.

    Participate in QE/QMS activities not specified here and as assigned.

    Review equipment documents and ensure all defined requirements are met.

    Collaborate well with team members throughout Noah organization.

    Support Good Manufacturing Practices and quality management system in accordance with FDA regulatory and ISO 13485 requirements.

    Other related assignments and support for manufacturing

    About You:

    Education:

    BS degree in a technical field or equivalent.

    BS in Engineering or Technology, Mechanical, Industrial, Electrical, Manufacturing, Life Sciences, or equivalent.


    Minimum of 6+ years of Engineering work experience in the medical device field and a minimum of 4 years' experience in a QE/Mfg.

    function or equivalent.

    Experience in production environments that meet world class regulatory requirements such as ISO/FDA Quality Management System requirements.

    Experience in inspection/test method development and validation for IQC, In-Process, and Final release requirements.

    Experienced with Process Validation including sterilization validation.

    Experience in supplier selection, qualifications and improvement.

    Experience with Risk Analysis, FMEAs, Hazard Analysis.

    Experienced with statistical skills to define/train on test sample size and data analysis techniques.

    Experienced in Microsoft Office and other software tools such as Google Suite and ePLM/eQMS systems, or equivalent.

    Must have attention to details, be a self-starter, a team builder, and excellent in verbal and written communication.

    Prior manufacturing experience in a medical device company, preferably on surgical robotics or equivalent highly complex medical devices.

    Strong team player with proven history of success working in a multi-disciplinary, cross functional team.

    Strong verbal and written skill with the ability to communicate effectively across functions and levels in the organization.

    Excellent people and project management skills

    Experience in MRP systems, MS office and related office automation systems.

    Experience in Medical Device Design Control processes preferred.

    Experience with sterilization processes.

    Workplace Type:

    Onsite

    Benefits & Perks (For Full Time Employees):

    Competitive Salary

    Comprehensive health insurance including Medical, Dental and Vision + HSA and FSA options

    Equity & Bonus Program

    Life Insurance (company paid & supplemental) and Disability insurance

    Mental health support through medical insurance programs

    Legal and Pet Insurance

    12+ paid holidays, 15-20 days of PTO + use-what-you-need sick days

    Paid parental leave

    In-office snacks and beverages

    In-office lunch stipend

    Learning & Development Opportunities:

    On-demand online training and book reimbursement

    Team building and company organized social and celebration events

    #J-18808-Ljbffr
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