Senior Business Quality Engineer – Non-Conformance Management (m/f) at WSA EMEA

Komorniki, Greater Poland Voivodeship, Poland -

Full Time

Start Date

Immediate

Expiry Date

23 Sep, 26

Salary

0.0

Posted On

25 Jun, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Non-Conformance Management, Root Cause Analysis, CAPA, ISO 13485, EU MDR, FDA Regulations, Quality Engineering, Process Harmonization, Stakeholder Management, Quality Event Management, Audit Support, KPI Monitoring, Medical Device Quality, Continuous Improvement, Deviation Investigations, Regulatory Compliance

Industry

Medical Equipment Manufacturing

Description

Driven by the passion to improve quality of life, WS Audiology continues to strengthen its global quality organization to support business growth, regulatory compliance, and operational excellence. What you will do As Senior Business Quality Engineer – Non-Conformance Management, you will play a key role in governing and continuously improving the global Non-Conformance (NC) process across regions, functions, and production sites. Acting as a global process owner and subject matter expert, you will ensure consistent and compliant execution of NC processes while driving process harmonization, issue resolution, and continuous improvement across the organization. Global Process Ownership Serve as a global process owner for Non-Conformance Management, ensuring consistent and compliant execution across sites and functions. Maintain and improve the NC process to support quality, compliance, and operational excellence. Monitor process performance through KPIs and quality metrics, driving transparency and process effectiveness. Support process harmonization and promote best practices across the organization. Quality Event Management Provide expert guidance on non-conformance management, investigations, root cause analysis, and CAPA activities. Support the assessment, escalation, and resolution of quality events in accordance with internal and regulatory requirements. Identify recurring trends and systemic issues, driving actions to reduce non-conformance recurrence. Act as a key point of contact for NC-related quality escalations. Compliance & Continuous Improvement Ensure NC documentation and records meet quality system and regulatory requirements. Support audits, inspections, and ongoing compliance with ISO 13485, EU MDR, and FDA requirements. Drive continuous improvement initiatives related to NC performance, quality trends, and operational risks. Support the implementation of a new global Non-Conformance Management system and other quality transformation initiatives. Stakeholder Collaboration Partner with Operations, Engineering, Quality, Regulatory Affairs, and other business functions to strengthen process effectiveness. Provide training and guidance to process users and stakeholders. Build alignment across functions and support effective issue resolution. What you bring Experience Bachelor’s degree in Engineering, Life Sciences, or another relevant technical discipline. 5+ years of experience in Quality Engineering, Quality Operations, Manufacturing Quality, or a related quality function within the medical device industry or another highly regulated environment. Strong experience with Non-Conformance Management, deviation investigations, root cause analysis, CAPA, and quality event management. Experience supporting manufacturing operations and quality systems in a regulated environment. Working knowledge of ISO 13485, EU MDR, and FDA regulations. Experience supporting audits, inspections, and regulatory compliance activities. Experience with quality systems implementation, process harmonization, or digital quality solutions is considered an advantage. Personal Competencies Strong communication and stakeholder management skills with the ability to influence across functions. Analytical mindset with a structured approach to problem solving and continuous improvement. Ability to manage multiple priorities and operate effectively in a fast-paced, global environment. Strong collaboration skills and ability to work across cultures and organizational boundaries. Committed to quality excellence, compliance, and continuous improvement. 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 role involves governing and improving the global Non-Conformance process to ensure consistent and compliant execution across all sites. Key duties include managing quality events, driving root cause analysis, and ensuring adherence to regulatory standards like ISO 13485 and EU MDR.