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.
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; two years of Quality Engineering experience; or equivalent combination of education and experience.
Knowledge of manufacturing processes and testing methods.