Summary: Ensures the verification, validation, manufacturing and testing of products meets customer expectations, industry standards, quality and regulatory requirements; performs investigations and testing to resolve quality issues. Essential Duties and Responsibilities: <ul><li>Develops and initiates quality plans from engineering drawings; meets company requirements for FDA and ISO design control as well as customer requirements.</li><li>Determines gage and fixture requirements.</li><li>Performs risk mitigations activities (PFMEA, Control Plans, Validations, Internal Audits and GR&R).</li><li>Analyzes quality data, identifies problem areas, and assists in resolving manufacturing processes or methods that affect quality.</li><li>Performs Design of Experiments.</li><li>Assists with the inspection of components and final assemblies.</li><li>Initiates and performs mechanical testing.</li><li>Performs process capability studies; recommends changes to improve quality.</li><li>Participates on cross functional teams to address and resolve quality problems.</li><li>Acts as a liaison to resolve customer issues, both internal and external.</li><li>Applies continuous improvement methods to enhance manufacturing processes, quality, reliability, and/or cost-effectiveness.</li><li>Performs internal and supplier audits.</li><li>Performs other assignments as necessary.</li><li>Maintains a professional working relationship and effectively communicates with all employees, managers, vendors, customers and regulatory agencies.</li><li>Understands and complies with company policies and procedures, regulatory requirements and safety regulations.</li><li>Regular attendance at work is required.</li></ul> Qualifications: <ul><li>Bachelor's Degree in Mechanical or Biomedical Engineering or related field; five years of Quality Engineering experience; or equivalent combination of education and experience.</li><li>Knowledge of manufacturing processes and testing methods.</li></ul>

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