QA Specialist

We Make Life More Rewarding and Dignified 

Location: ​Roosendaal​
Department: ​Quality 

As a Quality Specialist, you support the facility’s quality system to ensure compliance with all legal and regulatory requirements. You manage procedures and documentation, prepare and guide audits, and collaborate closely with operational departments to achieve both local and global quality objectives—aligned with Hollister’s mission and vision. 

Main tasks and responsibilities:

• Act as the local representative for global compliance projects, serving as the point of contact for change control and impact communication;
• Lead root cause investigations for external complaints and internal quality issues, and coordinate corrective actions, including those resulting from internal audits;
• Manage electronic documentation workflows for the creation and revision of quality-controlled documents, ensuring alignment with corporate standards, ISO, and FDA requirements;
• Conduct internal audits in accordance with the annual audit schedule;
• Support root cause analysis and follow-up actions for local CAPAs (Corrective and Preventive Actions);
• Participate in regulatory audits as needed, such as ISO and MDSAP;
• Perform other quality-related tasks as assigned by management.

Your profile:

• MBO 4 or HBO bachelor’s degree, preferably in medical device engineering, pharmaceutical sciences, food science, or a related technical field;
• 2 to 5 years of relevant work experience, ideally within a GMP-regulated pharmaceutical or medical device environment;
• Strong communication skills, with fluency in both English and Dutch (spoken and written);
• Solid knowledge of ISO 13485, GMP, and GDP standards.

Our application process:

1. First interview with the Supervisor Quality and Human Resources;
2. Second interview with the Global Quality Manager Distribution and Human Resources;
3. All positive? Let's get started!

Are you exited and see a match between your skills and this role? Click the “Apply now” button and we’ll get in touch with you as soon as possible. Do you have any questions or are you unsure whether your profile fits the position? Feel free to contact Dianta Foesenek at hrro@hollister.com or by phone at +31 6 82215794.

About Hollister Incorporated
Hollister Incorporated is an independent, employee-owned company that develops, manufactures and markets healthcare products worldwide. The company spearheads the advancement of innovative products for ostomy care, continence care and critical care, and also creates educational support materials for patients and healthcare professionals. Headquartered in Libertyville, Illinois, Hollister has manufacturing and distribution centers on three continents and sells in nearly 80 countries. Hollister is a wholly owned subsidiary of The Firm of John Dickinson Schneider, Inc., and is guided both by its Mission to make life more rewarding and dignified for people who use our products and services, as well as its Vision to grow and prosper as an independent, employee-owned company, and in the process, to become better human beings.

EOE Statement
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Job Req ID: 34829