Quality/Validation Engineer

2 weeks ago

Grafton, United States Gauthier Biomedical Full time

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:

  • Bachelors 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.

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