Personas orientadas a mejorar, crear y mantener productos y proveedores de calidad así como establecer los protocolos para una mejor interactuación de los departamentos.

Quality Assurance Specialist Job #077-14

Location: Westford, MA

Job Purpose:

The QA Specialist – Calibration performs quality activities in support of new and existing products. The primary focus of this position is to act as the primary owner of the Cynosure calibration program. In this function the QA Specialist will oversee the site program to assure that all equipment at the manufacturing site and in the field is properly calibrated. The QA Specialist – Calibration will also support the QA organization and will perform a wide variety of activities to ensure compliance with applicable regulatory requirements; such as documentation reviews; conducting quality audits; assisting with employee training; quality database maintenance; and data analysis.

Key Results Area:

  • Maintain the site Calibration program. Generate monthly reports and work with all departments to assure that gages are returned to QA to allow them to be calibrated.
  • Act as the main contact coordinating calibration activities with outside calibration houses. Work to either send the equipment out or coordinate with the labs to have Technicians visit the site to perform calibration.
  • Work with Quality Engineering and Engineering Departments to perform impact assessments for gages that have been found to be out of calibration when tested by the calibration laboratories.
  • Own the site Calibration SOP and make updates as required to ensure full regulatory compliance.
  • Serve as a back up to maintaining Complaint Files and facilitating investigations.
  • Assist QA Department as required supporting quality system activities in areas such as CAPA, Training, DHR Review, and Supplier Management.
  • Aid in the tracking and trending of CAPAs, Product Complaints, Audits, and Employee Training through the use of various databases and statistical tools.
  • Prepare and update Quality Assurance documents to ensure conformance with the regulations and guidelines.
  • Participate in departmental and interdepartmental meetings to help resolve product/process issues.
  • Support special project team activities and/or investigations, as needed.

Critical Competencies:

  • Demonstrated knowledge of scientific principles in a GMP/ISO regulated environment.

Behavioral and Interpersonal:

  • Strong oral and written communication abilities
  • Ability to manage high job complexity – prioritize and meet multiple customer requirements
  • Must demonstrate good communication skills and the ability to work independently.
  • Strong attention to detail

Supervisory Responsibility:

  • None

Sphere of Influence:

  • This position provides support to our internal customers and employees.
  • Highly visible position that interacts with all levels of the Company.

Education and Experience Requirements:

  • Bachelors degree in a scientific discipline, or equivalent experience. Recent college graduates with an engineering background will be considered.
  • 2-5 years of related experience preferred.
  • Prior experience coordinating a calibration program, handling customer complaints or reviewing DHRs is a plus.

If interested, please apply here