Manager, Quality System and Regulatory Affairs

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 elements at Unitron Hearing comply with all appropriate medical device standards and that international regulatory requirements are met.

 

You will be responsible for:

  • Maintains, updates and reports on Unitron’s Quality Management System (QMS) to ensure continued compliance to relevant standards such as ISO13485.
  • Ensures that all quality system methodologies are in compliance with government regulations and relevant standards such as MDSAP, MDD, MDR etc. 
  • Validates quality processes by establishing quality system attributes; documenting evidence; writing, updating and/or reviewing and approving QMS procedures.
  • Collaborates with Sonova headquarters (HQ) to achieve greater global quality system alignment (shared procedures, information tools, processes).
  • Maintains and improves the quality system by completing or coordinating product, company, system, compliance audits.
  • Prepares quality documentation and reports by collecting, analyzing and summarizing information and trends including failed processes, recalls, corrective actions/preventive actions and re-validations.  
  • Selects, appraises and disciplines assigned staff, in accordance with corporate policies and procedures.
  • Oversees projects/assignments of subordinates; ensures adherence to deadlines and objectives.
  • Maintains and controls information system that ensures relevant personnel are informed regarding pertinent quality and reliability issues.

   

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 medical device or hearing aid field
  • ASQC certification, preferably “Certified Quality Engineer”.
  • Certificate and/or training in risk management for medical devices and ISO 14971, biological safety and QMS – Internal Auditing
  • Quality assurance and supervisory experience.
  • 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. Sonova is an equal opportunity employer. Applicants who require reasonable accommodation to complete the application and/or interview process should notify the Director, Human Resources.

Sonova's hiring practices are aligned with human rights laws, which guarantee every person equal treatment in regard to employment and opportunity for employment, regardless of race, color, creed/religion, sex, sexual orientation, marital status, age, mental or physical disability.