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Product Quality Manager - Medical Devices
Posted 1 hour 19 minutes ago by Danone
Permanent
Full Time
Healthcare & Medical Jobs
Zuid-Holland, Zoetermeer, Netherlands, 2711 AA
Job Description
About The Job Product Quality Manager - Medical Devices (Zoetermeer - Fulltime /Hybrid) Nutricia Medical Devices is part legal manufacturer and part distributor. The Product Quality Manager ensures the quality and patient safety requirements for products sourced from NMD suppliers are sustainably met by quality in design, product verification, supplier management, and quality in logistics. Your main responsibilities are 
- Ensure the products delivered by NMD suppliers consistently meet the agreed specifications;
- Verify and monitor purchased products and/or components;
- Ensure quality requirements are met in logistics and distribution;
- Working closely with 3PL, CBU, planning and deployment teams to address quality issues in logistics and distribution;
- Provide Quality input into innovation, maintenance, and booster pipeline, validating project phase transitions (risk assessments, specifications, processing and design requirements);
- Ensure quality requirements are integrated into product design;
- Support monitoring and improvement of supplier quality performance, alongside supplier quality team. E.g. KPI reporting, supplier qualification, quality review, CAPA and SCAR, line validation;
- Support to conduct supplier audits and follow up, alongside supplier quality team;
- Manage supplier quality documentation and records, alongside supplier quality team;
- Work closely with cross-functional teams, including Quality, RA, C&P, R&I, Operation, and Marketing, to address quality issues and safeguard product quality;
- Harmonize the ways of working between medical device and food Coman quality management;
- Perform Internal audits as applicable.
- Bachelor's degree in Engineering/Quality Management or a similar field;
- Extensive years of experience with Medical Devices in Quality Management;
- Strong knowledge of ISO 13485 and MDR;
- In-depth understanding of medical device products;
- Proven experience in supplier audits and assessments;
- Demonstrated expertise in logistics/distribution quality management;
- Proven experience in design product quality or design transfer
- Can-do attitude with resilient, flexible, and proactive mindset;
- Excellent problem-solving and analytical skills;
- Strong communication and interpersonal abilities;
- Ability to work independently and collaboratively;
- Fluent in English
- Ability to travel to Europe or Intercontinental (20%)
- all applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status
Danone
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