Who we are

You enjoy creating and innovating. You never stop striving for better. You take responsibility and you get results. You love being part of a team. Above all, you want your work to matter: Welcome to our world! At Sonova we create sense by bringing sound to life. Our innovative hearing care solutions help millions of people enjoy life’s unforgettable moments.

We offer exceptional career opportunities through market-leading brands from consumer to medical, products and services that keep pushing hearing care forward, and a culture where you can quickly belong and perform at your best.

If you want the freedom to explore, opportunities to grow, and make positive change on people lives through your work, this is the place for you.

Join Sonova. Create sense.

Aurora (IL), United States

Sr. Manager, Quality Management System

Position Name

Sr. Manager, Quality Management System

Position Holder

N/A

 

Group Company

Sonova USA Inc.

Functional Area

Quality Operations

Department

Quality Assurance

Cost Center

5100010410

Reports to (Position Name):

Director, Quality Leader Americas

 

Leadership Responsibility

Yes   No

 

Purpose of the Job

Sonova USA is seeking a Sr. Manager, Quality Management System who will be responsible for managing the Quality Management System (QMS) within Sonova USA Inc and Aurora Operations and Distribution Center (AODC).

The position will drive the success of key QMS processes as assigned, including CAPA, nonconformance, internal & external audits, KPI metrics, document and training management, and local management review. 

 

This position is a leadership position and will be based out of Aurora, Illinois.

Key Tasks & Responsibilities

  • Improve the CAPA and NC process, and drive the timely closure and effectiveness of CAPA and NC.
  • Work with multidisciplinary teams with headquarters and within Sonova USA to manage problem solving and improvement projects and initiatives.
  • Ensure generated metrics are reported consistently throughout the organization.
  • Analyze trends and collaborates with manufacturing to investigate trends, conduct root cause analysis and lead corrective actions for processes and products.
  • Drive functional excellence of QMS document management and training management.
  • Manage internal and external audits.
  • Lead quality related meetings.
  • Work with in-house ERP, CRM, DMS systems and other databases
  • Use risk approach for decision-making.
  • Other duties as assigned.

Travelling Requirement

5%.

 

 

 

Qualifications

 

 

Need to have

 

 

Nice to have

Basic Education

BS in an Engineering, Science, or related field required

-ASQ Certification (CQE, CQM, CSSBB, CQA, or other) desired

-Certification in internal audit for ISO 13485, ISO 9001 desired

 

Further Education

 

 

Work Experience

Experience to manage quality management system in a medical device company for 5 years.

Former people management experience is required.

 

Former MDSAP implementation experience is preferred.

Personal Competencies

-Strong organizational skills

 

Social Competencies

-Strong verbal and written communication skills

 

Leadership Competencies

-Good project management skills: capable of effectively managing multiple projects and objectives concurrently

-Strong interpersonal and leadership skills, particularly across functions

 

Professional Competencies

-Solid understanding of medical device manufacturing and regulations (ISO 13485, FDA QSR)

-Strong analytical skills; technical and conceptual attitude

-Knowledge of statistics and analytical problem-solving tools is a strong plus

-Minitab experience is a plus

-Electronics, acoustics, and / or industrial engineering knowledge is a plus

 

Language(s) / Level

 

 

IT skills

Proficient at data analysis in ERP, CRM, DMS and other Database.

 

Further Requirements

-Position requires work in both office and manufacturing environment

-Standing, sitting, walking, reaching with hands and arms to perform keyboard entry, manipulation of computer accessories, inspection of tools / controls

-Reach with hands and arms, talking and hearing

-Employee will occasionally lift and/or move product, tools, etc.

 

 

Additional Remarks:

 

Sonova is an equal opportunity employer.

We team up. We grow talent. We collaborate with people of diverse backgrounds to win with the best team in the market place. We guarantee every person equal treatment in regard to employment and opportunity for employment, regardless of a candidate’s ethnic or national origin, religion, sexual orientation or marital status, gender, genetic identity, age, disability or any other legally protected status.