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Jobs at bloom Hörakustik (Now Hiring) — 14 open

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Head of Business Quality, Global Operations Processes (m/f)

Komorniki, Greater Poland Voivodeship, Poland · On-site

Senior+

Driven by the passion to improve quality of life, WS Audiology continues to expand access to hearing care through innovative solutions, strong brands, and operational excellence. As part of our ongoing transformation, we…

Skills: Non-Conformance Management, Quality Governance, Root Cause Analysis, CAPA, ISO 13485

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

Komorniki, Greater Poland Voivodeship, Poland · On-site

Senior

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 Se…

Skills: Non-Conformance Management, Root Cause Analysis, CAPA, ISO 13485, EU MDR

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Program Manager, Lifecycle Management

Lillerød, Capital Region of Denmark, Denmark · Hybrid

Senior

Driven by the passion to improve quality of people’s lives, WSA continues to grow as a market leader in the hearing aid industry. With our commitment to increase penetration in an underserved hearing care market, we want…

Skills: Program Management, Lifecycle Management, Stage Gate Governance, Risk Management, Supply Chain Optimization

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Specialist Business Quality Support EMEA

Komorniki, Greater Poland Voivodeship, Poland · Hybrid

Mid level

Kierując się pasją poprawy jakości życia ludzi, WSA nieustannie rozwija się jako lider rynku w branży aparatów słuchowych. Jesteśmy stale zaangażowani w rozwój zmieniającego się rynku usług leczenia problemów ze słuchem …

Skills: English Proficiency, ISO 13485, ISO 9001, Quality Management Systems (QMS), CAPA

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Product Manager – ERP & Data, Global Retail XP

Lillerød, Capital Region of Denmark, Denmark · On-site

Senior

Driven by the passion to improve quality of people’s lives, WSA continues to grow as a market leader in the hearing aid industry. With our commitment to increase penetration in an underserved hearing care market, we want…

Skills: Product Management, Microsoft Business Central, ERP Strategy, Data Governance, Roadmap Development

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CRM Student Assistant

Lillerød, Capital Region of Denmark, Denmark · On-site

Entry level

Driven by the passion to improve quality of people’s lives, WSA continues to grow as a market leader in the hearing aid industry. With our commitment to increase penetration in an underserved hearing care market, we want…

Skills: Salesforce, Excel, CRM, Analytical Mindset, Customer Experience

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Senior Engineer, Sound & Audiology

Erlangen, Bavaria, Germany · On-site

Mid level

Driven by the passion to improve quality of people’s lives, WSA continues to grow as a market leader in the hearing aid industry. With our commitment to increase penetration in an underserved hearing care market, we want…

Skills: Audiology, Acoustics, Signal Processing, Matlab, Python

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Lojistik Elemanı

Kartal, Marmara Region, Turkey · On-site

Entry level

Yaşam kalitesini artırma tutkusuyla hareket eden şirketimiz, işitme çözümleri pazarında lider konumunu güçlendirirken lojistik süreçlerinde de mükemmelliği hedeflemektedir. Bu pozisyon, tedarik zinciri operasyonlarımızın…

Skills: Inventory Management, Warehouse Operations, Shipping And Receiving, SAP, WMS

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Expert Produit Widex - Audioprothésiste H/F

Saint-Ouen-sur-Seine, Ile-de-France, France · Hybrid

Mid level

Animée par la passion d'améliorer la qualité de vie, WS Audiology se positionne comme un leader incontournable du marché des aides auditives. Notre ambition ? Répondre aux besoins d’un marché des soins auditifs encore so…

Skills: Pedagogy, Training Animation, Hearing Aid Technology, Technical Expertise, Customer Relationship Management

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Product Manager, CRM Service & AI

Komorniki, Greater Poland Voivodeship, Poland · On-site

Senior

Driven by the passion to improve quality of people’s lives, WSA continues to grow as a market leader in the hearing aid industry. With our commitment to increase penetration in an underserved hearing care market, we want…

Skills: Product Management, Salesforce Service Cloud, AI Implementation, CRM Strategy, Agile Methodology

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Formateur Audiologie Itinérant - secteur NORD OUEST - H/F

Brest, Brittany, France · Remote OK

Senior

Animée par la passion d'améliorer la qualité de vie, WS Audiology se positionne comme un leader incontournable du marché des aides auditives. Notre ambition ? Répondre aux besoins d’un marché des soins auditifs encore so…

Skills: Audiology Expertise, Technical Training, Customer Relationship Management, Pedagogy, Technical Support

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Head of Retail Operations, Netherlands

The Hague, South Holland, Netherlands · Hybrid

Senior+

WSA, driven by a passion for improving lives, is a leading force in the hearing aid industry. We are committed to innovation and excellence in healthcare solutions. The Head of Retail Operations is responsible for the ov…

Skills: Retail Operations Management, Strategic Execution, Financial Management, KPI Management, Clinic Portfolio Management

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Technical Software Product Manager, Customer Identity and Access Management (m/f/d)

Lillerød, Capital Region of Denmark, Denmark · On-site

Senior

Driven by the passion to improve quality of people’s lives, WSA continues to grow as a market leader in the hearing aid industry. With our commitment to increase penetration in an underserved hearing care market, we want…

Skills: CIAM, Product Management, OAuth2, OpenID Connect, SAML

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Architect, Cloud Applications (m/f/d)

Lillerød, Capital Region of Denmark, Denmark · On-site

Senior

At WSA, we combine deep audiological insight with advanced engineering to create hearing solutions that truly improve people’s lives. Our work bridges science and technology—translating complex challenges into meaningful…

Skills: Cloud Architecture, Hybrid Application Design, WebAssembly, Offline Sync Architecture, Agile Methodology

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Head of Business Quality, Global Operations Processes (m/f)

bloom Hörakustik

Komorniki, Greater Poland Voivodeship, Poland • On-site

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Senior+

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  • Full-time
  • bachelor degree, postgraduate degree
  • Posted 2d ago
  • ~40 hrs/week

Responsibilities

The role serves as the Global Process Owner for Non-Conformance Management and other quality operations processes to ensure regulatory compliance and standardization. It involves leading critical quality escalations, driving continuous improvement initiatives, and managing a global team to maintain operational excellence.

Requirements

Candidates need a Bachelor's degree in Engineering or Life Sciences and over 10 years of experience in quality functions within the medical device industry. Proficiency in ISO 13485, EU MDR, and FDA regulations, along with a proven track record of governing global quality processes, is required.

Full job description

Driven by the passion to improve quality of life, WS Audiology continues to expand access to hearing care through innovative solutions, strong brands, and operational excellence. As part of our ongoing transformation, we are strengthening our global quality organization and looking for a leader to drive standardization, governance, and continuous improvement across critical operational quality processes.

What you will do

As Head of Business Quality, Global Operations Processes, you will own and govern key global quality processes across Operations, ensuring consistent execution, regulatory compliance, and continuous improvement across the organization.

The role serves as the Global Process Owner for Non-Conformance Management and selected Quality Operations processes, including Validation, Operational SOPs, NPI, and Design Transfer. You will act as the central point of contact for quality escalations, process governance, and cross-functional quality improvement initiatives.

Global Process Ownership & Governance

  • Serve as the Global Process Owner for Non-Conformance (NC) Management, ensuring standardized and compliant execution across regions and production sites.

  • Govern global quality operations processes, including Validation, Operational SOPs, NPI, and Design Transfer.

  • Define process standards, KPIs, and governance frameworks to drive consistency and effectiveness.

  • Drive harmonization of quality processes, systems, and best practices across global operations.

Quality Operations & Escalation Management

  • Lead critical quality escalations arising from non-conformances and operational quality events.

  • Ensure timely investigation, documentation, escalation, and closure of quality events in line with internal and regulatory requirements.

  • Facilitate effective root cause analysis and CAPA implementation to prevent recurrence.

  • Provide visibility and decision support for high-impact quality issues.

Continuous Improvement & Compliance

  • Monitor process performance through quality metrics and trend analysis, identifying opportunities for improvement and risk reduction.

  • Drive continuous improvement initiatives related to NC management, operational quality processes, and systemic quality risks.

  • Ensure compliance with applicable regulations and standards, including ISO 13485, EU MDR, and FDA requirements.

  • Support internal audits, external audits, and regulatory inspections.

Leadership & Stakeholder Management

  • Lead and develop a growing team responsible for global quality process governance.

  • Build strong partnerships across Operations, Engineering, Customer Service, Commercial, Regulatory Affairs, and Quality functions.

  • Influence stakeholders at all levels to drive alignment, accountability, and operational excellence.

Strategic Projects

  • Lead the implementation of a new global Non-Conformance Management system.

  • Drive process harmonization and change management initiatives.

  • Support strategic quality and business transformation projects across the organization.

What you bring

Experience

  • Bachelor's degree in Engineering, Life Sciences, or a related technical discipline; Master's degree preferred.

  • 10+ years of experience in Quality Engineering, Quality Operations, Manufacturing Quality, or related quality functions 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.

  • Proven experience governing global quality processes and driving cross-functional process improvements.

  • Experience supporting manufacturing operations and operational quality processes in a global environment.

  • Demonstrated experience working with quality management systems and regulatory requirements, including ISO 13485, EU MDR, and FDA regulations.

  • Experience supporting audits, inspections, and regulatory interactions.

  • Experience implementing, optimizing, or deploying quality management systems and digital quality tools is highly desirable.

Personal Competencies

  • Strategic mindset with strong leadership and decision-making capabilities.

  • Strong communication and stakeholder management skills, with the ability to influence without direct authority.

  • Proven ability to lead through complexity and manage high-priority quality escalations.

  • Analytical and data-driven approach to problem solving and process improvement.

  • Ability to operate effectively in a fast-paced, global environment with evolving priorities.

  • Strong commitment to quality excellence, compliance, and continuous improvement.

  • Collaborative leadership style with a passion for developing people and building high-performing teams.

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.

Related keywords

Medical DeviceQuality Management SystemISO 13485EU MDRFDANon-Conformance ManagementCAPARoot Cause AnalysisValidationNPIDesign TransferOperational SOPsQuality EngineeringManufacturing QualityGovernanceKPIs

About bloom Hörakustik

LinkedInVisit site

wir verstehen hören!

Industry
Medical Equipment Manufacturing
Company size
51-200 employees
Founded
2019
Headquarters
Hallein, Salzburg
LinkedIn followers
491

WIR VERSTEHEN HÖREN. Bei uns stehst du im Mittelpunkt. Damit du in Zukunft wieder mittendrin, statt nur dabei bist, bieten wir professionelle, persönliche und maßgeschneiderte Beratung, für welche wir 2023 zum dritten Mal in Folge erneut mit dem Siegel Branchenchampion im Bereich Hörgeräteakustiker ausgezeichnet wurden. Kundenservice heißt für uns zuzuhören und auf deine Bedürfnisse einzugehen. Hörlösungen der neuesten Generation, hochwertige Hörgeräte, Fachkompetenz und vor allem die beste, persönlichste Kundenberatung Österreichs sind die Stärken von bloom Hörakustik. Gehör schenken – das ist unser Ziel – und das in ganz Österreich! Daher befinden wir uns auf Wachstumskurs, um allen Österreicherinnen und Österreichern bald Gehör schenken zu dürfen. Im Gegenzug bieten wir attraktive und spannende Möglichkeiten, sich beruflich zu entwickeln - europaweit. 𝗭𝗲𝗶𝘁, 𝘇𝘂 𝗯𝗹𝗼𝗼𝗺𝗲𝗻 Bereit, die globale Hörindustrie neu zu gestalten? Schau dir doch einfach unsere Jobs an. 👇

Offices: Salzachtalstraße 24, Hallein, Salzburg 5400, AT · Löwenstraße 3, Schwarzach im Pongau, Salzburg 5620, AT · Hauptplatz 37, Voitsberg, Steiermark 8570, AT · Radetzkystraße 10, Graz, Steiermark 8010, AT · Fabriksgasse 1, Fürstenfeld, Steiermark 8280, AT

AudiologieHörgeräteHördienstleisterHörhilfenHördienstleisterMedizintechnikHörgeräteSigniaWidexand Cochlea
View all jobs at bloom Hörakustik

About bloom Hörakustik

LinkedInVisit site

wir verstehen hören!

Industry
Medical Equipment Manufacturing
Company size
51-200 employees
Founded
2019
Headquarters
Hallein, Salzburg
LinkedIn followers
491

WIR VERSTEHEN HÖREN. Bei uns stehst du im Mittelpunkt. Damit du in Zukunft wieder mittendrin, statt nur dabei bist, bieten wir professionelle, persönliche und maßgeschneiderte Beratung, für welche wir 2023 zum dritten Mal in Folge erneut mit dem Siegel Branchenchampion im Bereich Hörgeräteakustiker ausgezeichnet wurden. Kundenservice heißt für uns zuzuhören und auf deine Bedürfnisse einzugehen. Hörlösungen der neuesten Generation, hochwertige Hörgeräte, Fachkompetenz und vor allem die beste, persönlichste Kundenberatung Österreichs sind die Stärken von bloom Hörakustik. Gehör schenken – das ist unser Ziel – und das in ganz Österreich! Daher befinden wir uns auf Wachstumskurs, um allen Österreicherinnen und Österreichern bald Gehör schenken zu dürfen. Im Gegenzug bieten wir attraktive und spannende Möglichkeiten, sich beruflich zu entwickeln - europaweit. 𝗭𝗲𝗶𝘁, 𝘇𝘂 𝗯𝗹𝗼𝗼𝗺𝗲𝗻 Bereit, die globale Hörindustrie neu zu gestalten? Schau dir doch einfach unsere Jobs an. 👇

Offices: Salzachtalstraße 24, Hallein, Salzburg 5400, AT · Löwenstraße 3, Schwarzach im Pongau, Salzburg 5620, AT · Hauptplatz 37, Voitsberg, Steiermark 8570, AT · Radetzkystraße 10, Graz, Steiermark 8010, AT · Fabriksgasse 1, Fürstenfeld, Steiermark 8280, AT

AudiologieHörgeräteHördienstleisterHörhilfenHördienstleisterMedizintechnikHörgeräteSigniaWidexand Cochlea
View all jobs at bloom Hörakustik

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