Quality Assurance Specialist

Category

 

Join our growing team!

We offer many opportunities for advancement within the Amico Group of Companies, along with a comprehensive benefit package, employer paid vacation, and management approved tuition reimbursement and an employee referral program.

Due to our rapid expansion and global demand, Amico is looking for dynamic and energetic individuals who can excel in a fast paced environment. Amico develops world-class products and technology, and this role has significant career growth potential for the right candidates.

This role will involve ensuring compliance to and continuous improvement of our Quality Management System, as it relates to all aspects of the business.

Responsibilities will include but are not limited to:           

  • Updating and Maintaining Internal Quality Management Systems.
  • Report on the performance of QMS an identify any areas in need of improvement
  • Liaise with relevant external assessment body(ies) on all matters related to standards, certifications, accreditations, or compliance.
  • Collect and analyze Quality KPIs for progressive continuous improvement.
  • Ensure the promotion of customer requirements throughout the organization.
  • Active management of Complaints log and CAPA log to ensure timely and appropriate actions are taken.
  • Document control
  • Perform regular internal audits to ensure adherence to QMS, take corrective action where needed.
  • Perform Supplier Audits and write reports
  • Write, revise and update and validate SOPs and Work Instructions
  • Ensure that good manufacturing processes are established and maintained.
  • Ensure that QMS complies with current industry standards and requirement
  • Ensure all staff are inducted into the requirements of the QMS related to their own roles and responsibilities, provide updated training and documentation as required.
  • Co-ordinate continual improvements of the QMS, ensuring that evidence of corrective and preventive actions taken are recorded and reviewed.
  • Ensure that all suppliers used by the organization are selected, evaluated and reevaluated and that records of this assessment are maintained.
  • Ensure that Quality Objectives are set by top management for measuring the performance of the QMS and that these are regularly reviewed.
  • Perform other tasks related to quality assurance and control as needed.

Qualifications:

  • Min 5 years experience in Quality Assurance in an ISO environment
  • Knowledge of ISO 13485:2003
  • Experience in Quality assurance of Medical Devices is a plus
  • Strong critical thinking
  • High level of accuracy
  • Problem Solving
  • Experience in Support and Troubleshooting
  • Good computer and communication skills
  • Must be able to manage priorities and meet deadlines
  • Ability to work independently as well as part of a team

 

If you’re interested please send your resume to applyhr@amico.com.