- Assures compliance with regulatory requirements (ISO 13485, MDD, MDR) and other ISO standards. Provides GMP and FDA compliance support as necessary.
- Supports customers globally & ensure effective and timely communication of quality updates and issues.
- Supports warehouse and distribution Quality activities and manufacturing batch record review.
- Perform batch record review and Oracle release for client products, 3rd party products and spare parts.
- Support supplier 3PL warehousing globally to ensure issues are resolved to ensure high quality and timely availability of products for customers. Maintain relationships with personnel and provide logistical support for Change Control activities between our client and the 3PL warehouses.
- Support with Global warehousing for receiving, release, and returns.
- Represent QA in the monthly and quarterly 3PL warehouse supplier meeting.
- Provide quality oversight to international distributors and outsourced processes (manufacturing, warehousing, distribution, resale products, installation and maintenance) through quality agreements, audits, SCARs (supplier complaints), product and service monitoring and measuring.
- Support Quality part of tender preparation.
- Perform internal and/or supplier quality audits and facilitate corrective actions.
- Monitor and provide to the International team visibility about the quality system deliverables intended to be completed short term, for audits, complaints, supplier management, change control, non-conformities and CAPAs, and product release, relevant for the region.
- Review manufacturing batch record and relabeling batch record at warehouse.
- Assist with change control and CAPA program management, track activities, maintain documents, and prepare closures. Track quality reports to completion. Leads coordination calls if necessary (weekly or monthly).
- Review supplier documentation and help with routing in the Document Control system.
- Assist in compiling Quality KPI data and presentations. Assist as needed for data reviews and Management Reviews.
- Participate in continuous improvement activities in the Quality Department, including implementation of new or improved processes, tools and software.
- Participate in and/or represent Quality on project and tender teams.
- Revise SOPs/INSs, prepare flow charts and other quality documentation relevant for the region.
- Create and send customer letters for complaints, as needed.
- Perform other related duties as required.
- Experienced Quality professional with a post graduate quality degree, and a minimum of 5 years' experience in quality in an industry with strong quality regulations (preferably pharmaceutical or medical device).
- Preferred 3 years of Supplier Audit experience in the Medical Device or Pharmaceutical function
- Strong understanding of the FDA and GMP regulations and ISO 13485; MDR experience is a plus.
- Strong teamwork spirit.
- Strong communication skills (encompasses verbal, written, interpersonal, listening).
- Flexible; ability to adapt to changing priorities.
- Excellent time management skills (schedules, timelines, task prioritization).
- Fluent in English and French. Spanish is a plus
- Ability to travel 30 % with some international travel.
- Living within commutable distance from Amersfoort;
- Valid work permit for the Netherlands;
- Initially office-based, with the option to work from home 1 day per week after the onboarding period.
- 25 holidays per year (based on full-time);
- Compensated travel expenses;
- Pension plan from day 1;
€4500.00 - €5000.00 monthly