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RAQA Specialist - 1 Year Fixed Term Contract - Johannesburg, South Africa en Johannesburg a Stryker Corporation

Fecha de publicación: 2/11/2019

Resumen de la oferta

Descripción del empleo

The Job’s Mission

At Stryker patient safety is a primary concern, the RAQA Specialist is integral to ensuring compliance to all regulatory requirements in orders to reduce the level of risk to patients. Working within a highly complex and diverse region (EEMEA) the RAQA Specialist is responsible for the co-ordination and successful completion of the QA remediation plan for South Africa. Covering Stryker sites the RAQA Specialist will act as the assistant Project Manager to drive forward the remediation plan to develop and implement actions to ensure compliance to Stryker QMS and ISO13485 standards. A cross functional role that will positively impact every part of the business.

Key Activities & Accountabilities

  • Work closely with process owners to identify actions to be implemented to achieve compliance to the Stryker QMS and ISO13485 standards. Host regular meetings with Process Owners and RAQA to ensure actions are appropriately assigned, target due dates met and actions closed as effective.
  • Keeps up to date on overall activities of the team, identifying problem areas and taking corrective actions.
  • Coordinate Complaint Management
  • Act as assistant Project Manager to ensure the QA remediation plan for South Africa is successfully completed. Communication of the plan to all stakeholders, provision of regular progress updates to the RAQA manager.
  • Ability to resolve conflicts – and be able to make measured decisions in the best interests of the project objective.
  • Establishes, modifies, implements, and monitors systems and procedures to enhance timely and efficient workflow. Coordinates all parties to ensure one direction and conversation. Manages schedules and workflow. Assigns duties and monitors quality of work; assures staff conforms to organizational policies and procedures and government regulations.
  • Key liaison between business Process Owners and the local RAQA Manager. Responsible for the flow of information between department heads and local RAQA management.
  • Act as a Change Champion for the business to successfully drive forward the remediation plan. Embraces the spirit of positive change and supports the change effort and to ensure that once the project is completed, the changes are sustained.
  • Provide regular status updates to RAQA Manager. Assisting in the coordination and compliance of regulatory processes, license renewals and product registrations to ensure compliance of regulations for Medical devices.

Education

  • High School Diploma
  • Degree in medical field - desirable

Experience

  • Work experience in RA or RAQA (minimum of 2 years)
  • Experience of working in an multinational business environment is highly desirable

Competencies

  • Ability to build relationships with colleagues across multiple countries and cultures
  • Must be able to lead by influence, persuade and activate key stakeholders at all levels of the organization.
  • Excellent communication skills with proficiency in spoken and written English
  • Combination of analytical and abstract way of thinking
  • Collect, interpret, and/or analyse complex data and information
  • Resourceful self-starter who doesn’t require close supervision to meet tight deadlines and able to handle multiple and diversified tasks
  • Strong organizational, problem-solving, and analytical skills.
  • Ability to manage priorities and workflow.
  • Versatility, flexibility, and a willingness to work within constantly changing priorities with enthusiasm.
  • Acute attention to detail.
  • Demonstrated ability to plan and organize projects
  • Good judgment with the ability to make timely and sound decisions.
  • Creative, flexible, and innovative team player.

Work From Home: No

Travel Percentage: Up to 25%

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