Senior Specialist, Quality Engineering

 

 

Overview

 

The Senior Specialist, Quality Engineering supports quality engineering functions and helps monitor & improve the quality Management system.

What you’ll do:

 

• Responsible for the developing and executions of QMS software validations in compliance to external standards, regulations and Advanced Bionics procedures.
• Delivers support to the CAPA program by providing direction to the CAPA owners with respect to containment, correction, investigations, root cause analysis, determining appropriate corrective and preventive actions. Executes VOE’s (verification of effectiveness) specific to open CAPAs.
• Provides support to coordinate and conduct internal and external audits to evaluate and monitor Sonova's or distributor's processes and systems.
• Supports management in analyzing quality data and providing feedback and interpretation.
• Develops quality management related documents and reports.
• Other duties assigned.

 

Additional Key Responsibilities: Maintains and organizes quality records in accordance with governing

procedures and creates statistics of Key Performance Indicators or other metrics.

 

 

Travelling Requirement: Up to 20%

 

 

 

What you bring to the team:

 

 

Education

• Associates Degree in engineering, electronics or medical related- profession, or higher.

 

 

Work Experience

• 5+ years of previous Quality Engineering experience in a regulated FDA/ISO work environment

      Nice to Have

• Previous Medical Device experience

 

 

Personal Competencies

• Must be able to work with all levels of management and engineers.

 

 

Social Competencies

• Ability to work under pressure and meet project timelines

 

 

Leadership Competencies

• Experienced with providing guidance and direction on topics related to QMS compliance and risk assessments.

 

Professional Competencies

• Analytical problem solving Planning Ahead
• Results focus Taking timely action
• Striving for Self-Development

 

 

Language(s)/ Level

• English/ Proficient

 

 

IT Skills

• Microsoft Office/ Engineering Software

 

 

 

 

 

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: $91,200/yr - $ 136,800/yr (based on location)

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.