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:

• Develops and initiates quality plans from engineering drawings; meets company requirements for FDA and ISO design control as well as customer requirements.
• Determines gage and fixture requirements.
• Performs risk mitigations activities (PFMEA, Control Plans, Validations, Internal Audits and GR&R).
• Analyzes quality data, identifies problem areas, and assists in resolving manufacturing processes or methods that affect quality.
• Performs Design of Experiments.
• Assists with the inspection of components and final assemblies.
• Initiates and performs mechanical testing.
• Performs process capability studies; recommends changes to improve quality.
• Participates on cross functional teams to address and resolve quality problems.
• Acts as a liaison to resolve customer issues, both internal and external.
• Applies continuous improvement methods to enhance manufacturing processes, quality, reliability, and/or cost-effectiveness.
• Performs internal and supplier audits.
• Performs other assignments as necessary.
• Maintains a professional working relationship and effectively communicates with all employees, managers, vendors, customers and regulatory agencies.
• Understands and complies with company policies and procedures, regulatory requirements and safety regulations.
• Regular attendance at work is required.

Qualifications:

• Bachelor’s Degree in Mechanical or Biomedical Engineering or related field; five years of Quality Engineering experience; or equivalent combination of education and experience.
• Knowledge of manufacturing processes and testing methods.