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.
