Quality Engineer I

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

The purpose of this position is to provide Quality Engineering support for manufacturing activities at Advanced Bionics, LLC. This is a mid level engineering position in Quality Assurance.  The position includes the following activities; product/material dispositioning, continuous improvement activities, risk assessments, measurement and methodology review, provides daily training and creating/updating procedures and criteria for Quality Control and Receiving Inspection.

What you’ll do:

• Act as the lead engineer in Receiving Inspection (MRB), and serve all other MRB’s areas: (Implants, External, Final Packaging, RMA, Purge, Finished Goods and Receiving).
• Leads/conduct training for ALL inspectors in areas related to our quality system, inspection methods, sampling plans and equipment
• Conduct statistical analyses and evaluate process capability
• Support and leads yield improvement initiatives through the development and release of procedures.  Improving the inspection process and initiating Engineering Change Orders (ECO) as necessary
• Undertake projects or assignments as directed by management in an SME capacity.
• Plan and lead audits; provide recommendations for retraining and/or methods for improvement where necessary (quality of the products, processes, and or information systems)
• Serve as a technical resource for process improvements, such as alternate measurement/testing methodologies. Provides recommendations for retraining and/or methods for improvement where necessary (Tooling, gauges, fixtures)
• Lead corrective and preventive actions (CAPA) and risk assessments as necessary
• Lead SCAR investigations and work with SQA as well as suppliers to implement corrective actions
• Use of Root Cause Analysis to aid in investigation of product or process failures using various quality tools

What you bring to the team:

Education

• Bachelor's Degree in Mechanical, Biomedical or Industrial Engineering

Work Experience

• 2+ years’ experience as a quality engineer in a medical device company

Nice to Have

• Experience working in an ESD controlled environment
• Experience working with PCBAs
• Experience creating RIIs and FAIs

Personal Competencies

• Solution Oriented
• Critical Thinker
• Organized
• Team Player
• Proactive
• Self- Motivated
• Strategic Thinker
• Excellent Communicator

Social Competencies

• Ability to engage and interact with all members of the Advanced Bionics community
• Ability to collaborate with various functions

Leadership Competencies

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

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

Language(s) / Level

• Fluent in English

Nice to Have

• Fluent in Spanish

IT Skills

•   Microsoft Office Suite, SAP and PLM

Further Requirements

• Must have the ability to work on site full time

Nice to Have

• IPC-A-610 Certification
• IPC-A-600 Certification
• IPC-A-620 Certification
• ASQ CQE
• A3PS Experience

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.