Senior Engineer, Business Quality at WSA Americas

Biñan, Laguna, Philippines -

Full Time

Start Date

Immediate

Expiry Date

05 Jul, 26

Salary

0.0

Posted On

06 Apr, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Assurance, ISO 13485, ISO 9001, Regulatory Compliance, Manufacturing Process Compliance, Root Cause Analysis, CAPA, Validation Frameworks, 7QC Tools, Audit Readiness, Product Quality Management, Stakeholder Management, Medical Device Regulations, Process Documentation, Quality Management Systems

Industry

Medical Equipment Manufacturing

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. As a Senior Engineer, Business Quality, you will act as a key Quality Representative partnering closely with Operations, Engineering, and cross-functional stakeholders to ensure manufacturing excellence, regulatory compliance, and superior product quality. This role sits at the intersection of QMS governance and shopfloor execution, giving you direct impact on both process integrity and customer outcomes. What you will do Drive manufacturing process compliance and product quality in line with medical device QMS standards (e.g., ISO 13485, ISO 9001, MDR, QMSR) Lead resolution of production quality issues across lines, warehouses, and quality gates (IPQC, OQA) in collaboration with internal and external stakeholders Manage MRNs end-to-end, ensuring timely investigation, root cause analysis, and effective closure Oversee customer feedback and complaints related to Operations (e.g., workmanship issues, process deviations), ensuring robust CAPA execution and accurate reporting within systems Review and approve production and process documentation (e.g., WI, PFMEA, validation reports) to ensure audit readiness and compliance Own product returns management, coordinating cross-functionally to ensure proper disposition, execution, and system accuracy. What you bring Degree in Engineering with at least 5 years of QA experience in a manufacturing environment Exposure to medical device or regulated industries (e.g., hearing aids) is strongly preferred Strong working knowledge of ISO 13485, ISO 9001, auditing practices, and regulatory requirements (e.g., MDR, QMSR) Proficient in quality tools and methodologies (7QC tools, root cause analysis, CAPA, validation frameworks) Demonstrated ability to collaborate across functions and influence stakeholders at multiple levels Strong communication, presentation, and decision-making skills with a structured, problem-solving mindset. 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 and committed 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.

Responsibilities

The Senior Engineer will drive manufacturing process compliance and product quality in accordance with medical device standards. They will also lead the resolution of production quality issues and manage customer feedback and CAPA execution.