Senior Quality Engineer Audit/CAPA

Quality Assurance         ·             Valencia (CA), United States           ·         Full time

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

Senior Quality Engineer Audit/CAPA

Overview

Manage and take ownership of the CAPA processes for Advanced Bionics globally.  Support compliance of other quality assurance system processes at Advanced Bionics based on ISO 13485, MDSAP, EU MDR and other regulatory agency requirements, as applicable (e.g. CFDA), as directed by department leadership. 

What you’ll do:

• Lead the global corrective and preventive action system to ensure products and processes are continually improved.  May need to occasionally accommodate various time zones.
• Ensure CAPA activities for AB global quality system are conducted in a timely and effective manner by engaging resources throughout the organization.  This includes driving and motivating others to take actions, working with various departments to ensure resources are available to address CAPA activities based on quality and business priorities, and working with responsible individuals for thorough and accurate investigation, developing root cause analysis using tools such as 8D, 5 Whys, Fishbone, DMAIC, etc.  Documenting  corrective action and preventive action plans, and verifying effectiveness analysis.
• Interface with management and peers to assess and improve the adequacy of the processes. Analyze quality monitoring data sources and apply statistical techniques to identify existing and potential causes of non-conformances.  This includes but is not limited to the remediation of CAPA and NC deficiencies noted in audits and/or inspections. 
• Lead CAPA review board meetings and actively participate as a board member.  Manage the administration of CAPA review board meetings, including the processing of CAPA activities and database management.  Participate in the dissemination of CAPA process outputs and linkage to related processes including Management Review. 
• Effective CAPA data analysis and trending presenting the global CAPA process at Management Reviews. 
• Be responsible for generating data and maintaining compliance to the global Quality data metrics analysis, trending and reporting and proactively escalate issues.  Reporting KPI at Daily Management meetings
• Act as the SME for internal and external audits related to the CAPA process.
• Lead continuous improvement and maintenance of the QMS by maintaining an effective CAPA process.
• Be responsible for presenting the global CAPA process at Management Reviews and the SME for internal and external audits related to the CAPA process.
• Provide training to CAPA Owners on the CAPA Process
• Complete projects assigned by Sr. Director Global Quality Assurance or Head of Global Quality Assurance, including but not limited to:
  • Redlining or writing procedures, processing through change control
  • Supporting internal audit process, compliance to distributor audit schedule, performing Verification of Effectiveness (VOE) activities for CAPA and audit findings at AB sites globally
  • Development and/or execution of Quality Plans, and provide support for quality system improvement activities.
  • Provide backroom support during FDA, TUV and other regulatory inspections.

What you bring to the team:

Education: Bachelor’s Degree (Engineering, or related technical field is preferred)

Work Experience: Minimum of  5 years’ experience in medical device industry with experience in day-to-day management of quality system processes in an analytical capacity

Personal Competencies

• Good interpersonal skills 
• Solid organizational and planning skills and ability to work with minimal supervision
• Excellent critical analytical and problem solving skills, including consistent and effective problem solving, expert knowledge of Root Cause Analysis tools and applicable techniques (A3 problem solving, risk analysis, statistical analysis)  
• Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving non-conformances
• Ability to multi-task and have attention to detail while producing high quality work product

Nice to Have: Familiar with Continuous Improvement methodologies, including Six Sigma and statistical tools for data analysis

Social Competencies

• Must be effective in following up and prompting others to take action
• 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

Professional Competencies

• Good understanding of ISO 13485,  21 CFR 820, MDSAP, EU MDR and other applicable regulations
• Lead Auditor Certification/Training/Experience   

Language(s)/ Level: Fluent in English

IT Skills: Microsoft Word, Excel, PowerPoint and Access

Further Requirements: Must have the ability to work onsite and remotely as directed by management.

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 Senior Manager, Human Resources.

Pay Ranges:  $77,398/yr – $125,729/yr

Health Benefits & Perks:

• Medical, dental and vision coverage*
• Health Savings, Health Reimbursement, Flexible Spending/Dependent Care Accounts
• TeleHealth options
• 401k plan with company match*
• Company paid life/ad&d insurance
  • Additional supplemental life/ad&d coverage available
• Short/Long-Term Disability coverage (STD/LTD)
  • STD LTD Buy-ups available
• Accident/Hospital Indemnity coverage
• Legal/ID Theft Assistance
• PTO & paid holidays*
• Employee Assistance Program

Plan rules/offerings dependent upon group Company/location.

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.

Please click here to apply.