Senior Quality System Specialist

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About us:

Unitron is built on strong, personal relationships with hearing care professionals and products that make a real difference in the lives of people with hearing loss. Unitron has a proven track record of developing technological innovations that provide natural sound with exceptional speech understanding, and a relentless drive to deliver an exceptional customer experience.

It’s a great thing to work in a company that cares deeply about its people, and where the products we create make a real difference in people’s lives. It’s also a great thing to be a part of a culture that thrives on making the unexpected happen, and where team members’ work together to go the extra mile for customers.

We’re a company that believes in lifelong learning and in the development of our people. By investing in training, we enhance the skills of our people, build confidence, and up our competitive advantage in the hearing healthcare industry.

Job Summary

In this role, you will be responsible for ensuring that all Quality System requirements at Unitron comply with all appropriate medical device standards such as Medical Device Single Audit Program (MDSAP), Medical Device Directive (MDD), and ISO13485 as amended.

 

You will be responsible for:

  • Maintaining and supporting the Unitron Quality Management System to ensure continued compliance.
  • Ensuring that all development, manufacturing and Q.A. methodologies are in compliance with government regulations and relevant standards such as ISO13485 etc.
  • Coordinating risk management and usability processes within the project team
  • Completing biological safety of medical devices, assessment of accessories, assemblies and finished products.
  • Maintaining and improving Quality System by completing product, company, system, compliance audits; investigates customer complaints and collaborates with team members to introduce new products .
  • Preparing quality documentation and reports by collecting, analyzing and summarizing information and trends including failed processes via CAPA system. 
  • Maintaining and controls information systems that ensure relevant personnel are informed regarding pertinent quality and reliability issues.
  • Collaborating with external corporate Quality teams/individuals (some international travel is possible).
  • Performing other duties as required by Manager.

   

The experience you bring:

  • Diploma/degree in Electronics, Software and/or Mechanical Engineering. In the absence of an academic degree, must be able to demonstrate a successful track record in a relevant field.
  • Minimum 3 years’ experience in a hi-tech product/electronics environment or hearing aid field
  • ASQC certification, preferably “Certified Quality Engineer”.
  • Certificate and/or training in risk management for medical devices and ISO 14971, IEC62304 Medical Device Software, biological safety and QMS – Internal Auditing
  • Exceptional written and verbal communication skills
  • Ability to work independently and in a team environment.

 

We thank all applicants in advance; however only individuals selected for an interview will be contacted. All applications will be kept confidential. Unitron is an equal opportunity employer. Applicants who require reasonable accommodation to complete the application and/or interview process should notify the Director, Human Resources.