Join a leading medical device company as a Senior Supplier Quality Specialist. Drive continuous improvement initiatives with suppliers across Asia and EMEA, collaborating with cross-functional teams to enhance product quality and optimize processes. Be the primary quality contact for suppliers and provide strategic solutions based on data analysis. Discover how your talents can thrive in this environment.

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Panda International

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Senior Supplier Quality Specialist

For my client – a leading medical device company – I am looking for a Senior Supplier Quality Specialist to oversee supplier qualification, audits, and risk management while driving continuous improvement initiatives. This is a key role ensuring compliance with ISO 13485, ISO 9001, and MDR 2017/745 regulations across global suppliers.

Job Description: As a Senior Supplier Quality Specialist, you will be responsible for managing supplier quality across Asia and EMEA, ensuring adherence to industry regulations and company standards. You will play a critical role in supplier audits, CAPA management, and quality assurance while collaborating with cross-functional teams to enhance supplier performance and maintain a robust Supplier Quality Management (SQM) system.

Responsibilities:
Supplier Management and Oversight

Oversee and monitor the quality performance of multiple suppliers across Asia and EMEA.
Develop and maintain strong relationships with suppliers to ensure alignment on quality and operational goals.
Review of the supplier quality audits and assessments to ensure compliance with company standards, ISO 13485, ISO 9001, MDR 2017/745 and customer requirements.

Quality Assurance and Compliance

Establish and enforce supplier quality management processes, including quality control plans in coordination with the QA team.
Lead investigations (SCAR) into quality issues, working closely with suppliers to implement robust corrective and preventive actions (CAPA).
Ensure suppliers adhere to ISO 13485, ISO 9001, MDR 2017/745, or other applicable international standards and regulations.

Continuous Improvement

Drive continuous improvement initiatives with suppliers to enhance product quality, reduce non-conformances, and optimize supplier processes.
Collaborate with suppliers to implement process improvement methodologies.
Monitor supplier KPIs such as PPM, on-time delivery, audit results, complaints, and inspection results.

Collaboration and Cross-Functional Support

Work closely with internal teams, including Procurement, Quality & Regulatory, and Operations, to ensure supplier quality aligns with business goals.
Act as the primary quality contact for suppliers, facilitating communication and issue resolution.
Partner with the Supply Chain team to qualify new suppliers and manage supplier transitions where necessary.
Work closely with our stakeholders and colleagues in the Shanghai site.

Reporting and Data Analysis

Maintain accurate records of supplier performance, audits, and corrective actions.
Provide regular reports on supplier quality metrics, trends, and risks to senior management.
Utilize data analysis to identify systemic issues and implement strategic solutions.

Key Requirements:

Bachelor’s degree in Engineering, Supply Chain Management, or a related field (Master’s degree is a plus).
Minimum of 4 years’ experience in Supplier Quality Management, preferably in a global medical device manufacturing or supply chain environment.
Certified Quality Engineer (CQE), Six Sigma Green/Black Belt, or equivalent qualifications preferred.
Lead Auditor Certification for ISO 13485 is a plus.
Training on ISO 9001, ISO 13485, and MDR 2017/745.

Practicalities:

Location: Utrecht, The Netherlands – Hybrid
Language: English
Contract: Permanent
Start Date: ASAP

Interested? We want to hear from you! If you’re excited by this opportunity, send your CV to Khanyi Mabena at via de button "Solliciteer nu" op deze pagina. or call her on +31 2020 44502.

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Financieel Directeur Utrecht Fulltime Utrecht Vast contract Utrecht Utrecht Provincie Utrecht Financieel Directeur Salaris Financieel Directeur

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