Complaint Device Investigation Engineer (Failure Analysis)

WSAudiology; Calamba; On-site; PHP 600,000 - 800,000; Full time

Job summary

WSAudiology is seeking a Complaint Device Investigation Engineer to manage end-to-end investigations of returned hearing devices, identify root causes, and document findings.

You will work with global stakeholders, apply Power BI and Excel for data analysis, and support regulatory inspections, ensuring compliance with ISO 13485, FDA 21 CFR, and GMP.

Qualifications

• 3–5 years of failure analysis experience in a technical engineering role (medical device preferred; regulated manufacturing acceptable)
• BS in Engineering or Science (technical disciplines)
• Working knowledge of complaint handling regulations including ISO 13485, FDA 21 CFR, and GMP — ~30% of the role involves regulatory compliance work
• Proficiency in Power BI report development and Excel macro creation
• Demonstrated ability to write and present clear investigation reports for technical and non-technical audiences across global teams
• Strong multitasking and milestone management with the ability to handle multiple open investigations simultaneously

Responsibilities

• Conduct complaint device investigations from initial evaluation through root cause identification, escalation to RND or Engineering SMEs, and final documentation in the complaint file
• Perform failure analysis on returned hearing devices using bench-test equipment including oscilloscopes, signal generators, power supplies, and DC source/measure units
• Compile complaint data, prepare investigation reports, and coordinate findings with Complaint Handling and cross-functional global stakeholders
• Develop and maintain Power BI dashboards and Excel macros to track, analyze, and report complaint investigation data and trends
• Develop and maintain training materials and procedures for the complaint device investigation process
• Support internal and external regulatory inspections, audits, and management reviews related to complaint handling

Skills

Failure analysis

Regulatory compliance

Report writing

Multitasking

Milestone management

Education

BS in Engineering or Science

Tools

Power BI

Excel Macros

Job description

Driven by the passion to improve quality of people’s lives, WSA continues to grow as market leader in the hearing aid industry. With our commitment to increase penetration in an underserved hearing care market, we want to accelerate our business transformation in order to reach more people, more effectively.

Join our Quality team as Complaint Device Investigation Engineer where you'll play a vital role in handling complaint device investigations end-to-end: from returned product evaluation through root cause identification, escalation, and closure. You'll work closely with global stakeholders to ensure regulatory compliance and drive continuous improvement in our complaint handling processes.

What you will do

• Conduct complaint device investigations from initial evaluation through root cause identification, escalation to RND or Engineering SMEs, and final documentation in the complaint file

• Perform failure analysis on returned hearing devices using bench-test equipment including oscilloscopes, signal generators, power supplies, and DC source/measure units

• Compile complaint data, prepare investigation reports, and coordinate findings with Complaint Handling and cross-functional global stakeholders

• Develop and maintain Power BI dashboards and Excel macros to track, analyze, and report complaint investigation data and trends

• Develop and maintain training materials and procedures for the complaint device investigation process

• Support internal and external regulatory inspections, audits, and management reviews related to complaint handling.

What you bring

• 3–5 years of failure analysis experience in a technical engineering role; medical device (preferred), semiconductor, or other regulated manufacturing background accepted

• BS in Engineering or Science (technical disciplines)

• Working knowledge of complaint handling regulations including ISO 13485, FDA 21 CFR, and GMP — approximately 30% of the role involves regulatory compliance work

• Proficiency in Power BI report development and Excel macro creation

• Demonstrated ability to write and present clear investigation reports for technical and non-technical audiences across global teams

• Strong multitasking and milestone management skills, with a track record of handling multiple open investigations simultaneously under competing priorities.

Who we are

At WSA, we provide innovative hearing aids and hearing health services.

Together with our 12,000 colleagues in 130 countries, we invite you to help unlock human potential by bringing back hearing for millions of people around the world.

With us, you will become part of a truly global company where we care for one another, welcome diversity and celebrate our successes.

Sounds wonderful?We can't wait to hear from you.

WSA is an equal-opportunity employer andcommitted to creating an inclusive employee experience for all. Regardless of race, color, religion, national origin, age, sex, gender, gender identity, gender expression, sexual orientation, marital status, medical condition, ancestry, disability, military or veteran status we firmly believe that our work is at its best when everyone feels free to be their most authentic self.