Supplier Quality Manager (m/f/d)

Straumann Group; Madrid; Presencial; EUR 90.000 - 120.000; Jornada completa

Descripción de la vacante

Straumann Group in Madrid, Spain, seeks a Supplier Quality Manager to lead the global supplier quality program, ensuring compliance across manufacturing sites and third parties.

You will manage audits, NCRs, CAPAs, and qualification activities, coordinating with Procurement and Quality teams in a regulated medical device environment.

Formación

• Degree in a relevant field with strong quality systems background.
• Proven experience in quality management for medical devices or pharma.
• Experience in supplier quality management and supplier qualification processes.
• Knowledge of ISO 13485, MDR 2017/745, FDA 21 CFR 820 (QMSR).
• Auditor training and lead auditor certification is an advantage.

Responsabilidades

• Manage supplier onboarding, qualification, and monitoring processes.
• Define and implement supplier compliance strategies with Procurement and stakeholders.
• Establish and maintain Quality Assurance Agreements with suppliers/subsidiaries/distributors.
• Monitor supplier performance via KPIs and drive continuous improvement.
• Lead and develop the Supplier Quality Management team.

Conocimientos

Quality Management

Supplier Quality Management

Auditing

Leadership

Communication

Lean Management

Educación

University degree in Quality Management, Engineering, Life Sciences, Pharmacy, Medicine, Law

Herramientas

SAP

e-QMS

MS Office

Document Control Systems

Descripción del empleo

Are you ready to unleash your potential? At the Straumann Group, we\'re on an exciting journey of growth, innovation, and impact – driven by our mission to improve oral health and transform millions of lives worldwide. United by a shared goal, we give our best every day and cultivate a performance-oriented, player-learner culture that fosters collaboration, curiosity, and ambition. Here, you have the opportunity to actively shape your career and further develop your skills, passion, and willingness to learn. Together, we not only create more beautiful smiles but also unlock the potential of people – including our own.

As a Supplier Quality Manager (m/f/d), you will lead our Supplier Quality Management function and play a key role in ensuring compliance, quality, and supplier performance across the global Straumann Group. You will collaborate with internal and external stakeholders worldwide and drive continuous improvement within a highly regulated medical device environment. Your workplace will be in Madrid (Spain).

Your Responsibilities

Supplier Quality Management

• Managing supplier onboarding, qualification, and monitoring processes
• Defining and implementing supplier compliance strategies in collaboration with Procurement and other stakeholders
• Establishing and maintaining Quality Assurance Agreements with suppliers, subsidiaries, and distributors
• Monitoring supplier performance through KPIs and continuous improvement initiatives
• Leading and developing the Supplier Quality Management team

Quality Systems & Supplier Performance

• Investigating, reviewing, and approving supplier-related NCRs and CAPAs
• Assessing non-conforming products and determining appropriate disposition
• Supporting supplier qualification activities and ensuring compliance with regulatory and quality requirements
• Defining and harmonizing supplier compliance processes across Straumann Group manufacturing sites and third-party suppliers
• Collecting, analyzing, and reporting supplier quality data and KPIs to management

Supplier Audits & Compliance

• Managing the global supplier audit program and audit schedule
• Planning, coordinating, and conducting supplier quality audits as lead auditor
• Ensuring audit findings are effectively documented, addressed, and closed, including re-audits where required
• Defining and maintaining supplier audit procedures in compliance with applicable regulatory requirements
• Training and supporting internal auditors as part of continuous education activities

Incoming Inspection & Digital Process Ownership

• Defining and maintaining incoming inspection plans for the Basel warehouse
• Performing batch release activities based on quality certificates and documentation reviews
• Acting as Business Process Owner for supplier document management tools, including Product City lifecycle modules
• Defining user requirements, ensuring documentation, and coordinating user training

Your Profile

• University degree in Quality Management, Engineering, Life Sciences, Pharmacy, Medicine, Law or a comparable discipline
• Proven and strong professional experience in Quality Management, preferably within the medical device industry or pharma
• Proven experience in Supplier Quality Management and supplier qualification processes
• Strong knowledge of ISO 13485, MDR 2017/745, MDD 93/42/EEC, FDA 21 CFR 820 (QMSR), and related quality systems
• ISO 13485 Auditor Training, Lead Auditor certification is an advantage
• Experience conducting internal and external audits according to ISO 19011
• Strong knowledge of SAP, e-QMS systems, MS Office, and document control systems
• Lean Management Experience
• Fluent English skills, any additional languages are an advantage

What Makes You a Great Fit

• You are a hands-on leader with a strong implementation and solution-oriented mindset
• You communicate effectively and build strong relationships with internal and external stakeholders
• You thrive in international matrix organizations and can successfully influence decision-making processes
• You combine strong analytical thinking with excellent organizational skills
• You are passionate about quality, compliance, and continuous improvement
• You have experience leading teams and developing talent in a global environment
• You work with a high degree of integrity, accountability, and attention to detail

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