SUMMARY:
The Quality Manager shall complete Quality Assurance projects and recurring responsibilities in furtherance of the creation, implementation, and maintenance of the company Quality System. The primary focus of the Quality Manager shall be to perform the required duties to support the day to day operation of the company Quality System while adhering to ISO 9001 and ISO 13485 requirements. Works on complex problems where analysis of situations or data requires an in depth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods, techniques, and evaluation criterion for obtaining results. Work leadership may be provided by assigning work and resolving problems. Serve as the Quality Management Representative.

ESSENTIAL DUTIES AND RESPONSIBILITIES Include but are not limited to the following:

  • Responsibilities include drafting procedures and documents.
  • Manage Inspection Staff
  • Assisting employees with the understanding and performance of their Quality System responsibilities.
  • Analyzing the need for process changes.
  • Internal quality auditing assistance
  • Employee training when required
  • Document revision, document control assistance
  • Development of Control Plans and Inspection Guide sheets
  • Evaluation and interpretation of regulatory and standards schemes that are applicable. Other duties shall be defined, as necessary, by the VP of QA/Regulatory during the course of employment.
  • Organizational Management, Project Management and Team Management responsibilities.
  • Statistical analysis, Management reporting.
  • Technical writing and Procedure writing.
  • NCM/CAPA Management
  • Compliance to ISO 9001 and 1348

WORK ENVIRONMENT:
While performing the duties of this job the employee is regularly exposed to the basic “Machine Shop” and “Office” environments.

PHYSICAL DEMANDS:
While performing the duties of this job the employee is regularly required to stand, walk, sit, use hands to finger, handle, or feel, reach with hands and arms and talk or hear. The vision requirements include: Standard vision.

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