- Entry level
- No Education
- Salary to negotiate
JOB DESCRIPTION:Abbott is recruiting a Quality Assurance and Regulatory Compliance Specialist.
The QA/RC Specialist supports the North Europe Quality and Regulatory function, by proactively monitoring the QMS performance in line with corporate KPI’s, maintaining appropriate Quality records, implementing and monitoring compliance with procedures and has responsibility in the event of field actions.
Role and Responsibilities
- Organize, maintain and keep up-to-date a filing system for all Quality records, including all documents associated with Product Event reporting and Vigilance as agreed with the QA/RC Manager and in accordance with the requirements of relevant written procedures.
- Be an advocate for the Quality System
- Promote the benefits of and the need for working within Quality System procedures.
- Encourage staff to take ownership of the procedures that apply to their specific work area
- Participate in the review and follow-up of CAPAs.
- Ensure local procedures are up-to-date; relevant to current/best practice and that they meet the requirements of the Quality System.
- Use initiative and persistence to assist the QA/RC Manager to encourage continuous improvement of procedures, processes and practices, providing routine training to improve compliance where necessary.
- Maintain a detailed knowledge/awareness of the Standard Operating Procedures and Local Instructions covered by the Quality System.
- Provide training on the Quality system for new and existing staff where needed.
- Prepare for and follow-up on internal/external audits.
- Liaise with field staff to ensure requests for additional information from the manufacturing divisions are responded to without undue delay. Be the ‘interface’ between the manufacturing division and field staff.
- Monitor returns, liaising with field staff and customer service to ensure devices are returned to the local office without undue delay and that they reach the manufacturing division in a reasonable time, in accordance with the requirements of the field event reporting procedure.
- Address non-compliance with procedures for returning devices, reporting to the QA/RC Manager on serious or persistent issues.
- Coordinate and provide responses to routine requests for information on vigilance related issues, liaising with the manufacturing divisions as required.
- Experience in a similar role or in a detail-oriented administrative role
- Strong written and verbal English communication skills
- Dutch and French language skills preferred
- Knowledge of the local Medical Device regulation, relevant sections of the EU regulation, EU Medical Device Directives is an asset
- Ability to develop some technical understanding of the devices we sell
- Willing to address issues of non-compliance with procedures
- Able to work with sensitive and confidential information ensuring details remain highly confidential.
- Competent user of Microsoft Office packages.
JOB FAMILY:Operations Quality
LOCATION:Belgium Diegem : Building B
MEDICAL SURVEILLANCE:Not Applicable
SIGNIFICANT WORK ACTIVITIES:Not Applicable
About the company
At Abbott, we're committed to helping you live your best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 94,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.
Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and www.facebook.com/AbbottCareers, on Instagram @AbbottGlobal, and on Twitter @AbbottNews and @AbbottGlobal.
We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.