Manager, Quality Assurance
At Unitron, we share a commitment to make every interaction easy and personal; to genuinely listen and act on our customers’ input; and to have the best people on our team, each one committed to customer success. We care deeply about people with hearing loss. We work closely with hearing healthcare professionals to provide hearing solutions that improve lives in meaningful ways. Unitron is a member of the Sonova group – a global innovator of hearing solutions – you’ll have a world of places your career can take you.
In this role you will be, responsible for developing and analyzing software solutions for hearing aid market applications, hearing aid manufacturing and internal sales and marketing support. You will provide training and technical support for both internal and external customers.
In this role, you will be responsible for ensuring that all products developed, manufactured and/or distributed by Unitron comply with all appropriate medical device standards and perform their intended function.
- Maintains and reports on Unitron Quality Management System to ensure continued compliance.
- Ensures that all development, manufacturing and Q.A. methodologies are in compliance with government regulations and relevant standards such as ISO13485 etc.
- Validates quality processes by establishing quality attributes; documenting evidence; determining operational and performance qualification; writing and updating QMS procedures.
- Coordinates risk management and usability processes within the project team.
- Completes biological safety of medical device assessment of accessories, assemblies and finished products.
- Maintains and improves product quality by completing product, company, system, compliance audits; investigates customer complaints and collaborates with team members to introduce new products .
- Prepares quality documentation and reports by collecting, analyzing and summarizing information and trends including failed processes, stability studies, recalls, corrective 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.
- Develops and controls information system that ensures relevant personnel are informed regarding pertinent quality and reliability issues.
- Performs other duties as required by Director.
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, 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.
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