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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.

Valencia (CA), United States

Manager, Global Quality Systems

 

Covid Protocol:

Upholding the company values is extremely important to Sonova, we take the health and safety of our employees, patients, customers and their families very seriously. To that end, we have concluded that the best way to ensure the safety of these individuals is to mandate that all our newly hired employees be fully vaccinated for COVID-19. Therefore, when considering whether to apply for this position, please know that in order to become employed by Sonova (if otherwise eligible), you must provide satisfactory proof, such as a vaccine card or other documentation, that you are fully vaccinated for COVID-19. You will not be required to provide this proof unless and until you receive a formal job offer from Sonova. Please also know that Sonova will provide accommodations to qualified individuals who cannot receive the COVID-19 vaccination because of a sincerely held religious belief or due to a medical issue or pregnancy.

 

Overview:

 

Manage Advanced Bionics quality management system processes to ensure compliance to all relevant quality system regulations, including ISO 13485:2016, 21 CFR Part 820, all regulations applicable for MDSAP certification, EU Medical Device Regulation (MDR), and other regulatory agency requirements as applicable (such as S. Korea and Japan).

Responsibilities are focused on, but not limited to, the following global processes:

  • Management Review
  • Corrective and Preventive Action (CAPA)
  • Internal and external audits
  • Quality Training
  • Quality distributor management
  • Quality assurance functions at AB AG and at AB Group Companies, including supplier management and nonconformance management

Primary responsibility is to provide the leadership and direction for the above referenced quality system functions and teams to achieve quality system goals and objectives company-wide

Leadership and accountability includes identifying improvements, driving change, escalating issues to supervisor as appropriate, delegating tasks to subordinates.

This individual will be a strong and capable all-rounder, well-versed in all aspects of the quality system, with strong analytical and communication skills, and a willingness to take on projects as necessary to assist/lead continuous process improvements for the QA function, locally and globally. Lead/participate in other quality system projects as directed by department leadership.

 

 

What you’ll do:

 

Leading quality systems team to manage the following processes and activities to ensure quality management system compliance:

  • Manage global quality system processes across the organization, ensuring alignment of processes between legal manufacturer, authorized sites and group companies;
  • Manage global CAPA process, assisting team with investigations, root cause analysis, implementing corrective and preventive actions to ensure products and processes are continually improved.
  • Manage global Quality Training process to ensure compliance with documented training plans, training assignments, efficiencies of process, and trending/reporting;
  • Manage AB AG supplier audit process, including planning, performing supplier audits, and managing follow-up actions;
  • Primary lead in managing global internal audit process, including performing global distributor audits according to requirements and regulations;
  • Lead preparations for external audits and manage backroom and team in external audits to ensure a successful outcome;
  • Lead quality planning process, including development and/or execution of Quality Plans, and provide support for quality assurance team improvement activities;
  • Be responsible for ensuring administration of management review process, including updating procedures, coordinating approval of objectives, maintaining compliance to quality system data metrics analysis, trending and reporting, and proactively escalate issues to senior management;
  • Participate in quality system process risk management activities;
  • Lead and participate in various quality assurance improvement projects, as assigned.

 

What you bring to the team:

 

Education

 

  • Bachelor’s Degree, or related medical device experience.

 

Work Experience

 

  • 5+ years in a GMP, QSR, and ISO regulated implantable medical device environment, with proven writing experience in documentation for quality systems. 
  • Training and experience as a lead auditor. 

 

Personal Competencies

  • Excellent interpersonal communication skills with the ability to communicate both written and verbally.
  • Strong customer focused orientation.
  • Self-motivated, high level of initiative, with ability to work well in cross-functional teams
  • Commitment to elevating the team and improving our skills

 

Professional Competencies

  • Good interpersonal skills. 
  • Proven strength in organizational and planning skills and ability to work with minimal supervision.
  • Excellent critical analytical and problem solving skills, including consistent and effective problem solving, experience with Root Cause Analysis tools.
  • Ability to multi-task and have attention to detail while producing high quality work product.
  • Supervisory experience as a direct leader or proof of being effective in directing teams and individuals to take action and meet organizational commitments.
  • Proven expertise with ISO 13485,  21 CFR 820, MDSAP, EU MDR and other applicable regulations.

Nice to Have

  • Familiar with Continuous Improvement methodologies, including Six Sigma and statistical tools for data analysis.
  • Lead Auditor Certification

 

Social Competencies

  • Strong communication skills (written and verbal), must be able to write in a manner that effectively communicates complex issues

 

Leadership Competencies

  • Ability to lead projects with cross-functional participants to successful end goal.

 

Language(s) / Level

  • Fluent English / Proficient

 

IT Skills

  • Microsoft Word, Excel, PowerPoint and Access

 

Further Requirements

  • Must have the ability to work onsite and remotely as directed by management.  Some flexibility in work schedule to accommodate global time zone demands of the role.

 

Our offer:

  • Exciting and challenging work environment
  • Comprehensive benefits package
  • Training and development opportunities – we believe every employee deserves a development plan. Come, learn, and grow with us!

Don't meet all the criteria?  If you’re willing to go all in and learn we'd love to hear from you! 

We love to work with great people and strongly believe that a diverse team makes us better.  We 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.

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 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.