About Abbott

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading companies and products in diagnostics, medical devices, nutrition, and branded generic medicines. Our 109,000 colleagues serve people in more than 160 countries.

Primary Function

As a Sr. QA Officer, you will play a crucial role in ensuring that distribution processes, packaging processes, and other related processes are carried out in accordance with specifications and regulations to guarantee product safety and patient safety. The senior role is distinguished by functioning as an SME in specific parts of the quality system and actively contributing to improvement initiatives. The Sr. QA Manager also serves as a point of contact for the QA team and other departments.

Key Responsibilities (most important responsibilities)

• Quality Policy: Contribute to the development and maintenance of Abbott's quality policy and quality systems to ensure that business objectives are met for the distribution of Abbott products.
• Supervision and Advice: Continuously monitor the quality system and advise personnel on how activities should be performed in accordance with Abbott policies and legal regulations (such as GMP/FDA/HACCP/MDR) and quality standards (such as ISO9001 & ISO13485), to ensure product safety, quality, and patient safety.
• External Audits: Facilitate and support the effective and efficient execution and follow-up of external audits.
• Internal Audits: Responsible for executing and following up on the internal/supplier audit program.
• Continuous Improvement: Continuously evaluate the performance of assigned quality processes and support and implement improvement programs.
• Projects: Actively participate in projects as a project member.
• Validation: Participate in projects and advise on the classification and requirements for the execution of system/equipment validation. Review and authorize validation protocols and reports, and be ultimately responsible for the release of a system/equipment after validation.
• Distribution: Support all QA processes related to distribution activities.
• Packaging: Support packaging activities in accordance with QA procedures and GMP, and review the results for release.
• Complaints: Support the investigation and handling of complaints.
• Deviations: Support the process regarding deviations, change control, and CAPA.
• Documentation System: Support the document management process, including the creation of QA-related procedures in accordance with Abbott policy.
• Cleanliness: Ensure the quality system concerning cleaning and pest control programs.
• Quality Awareness: Contribute to the quality awareness of Abbott colleagues by actively sharing knowledge and contributing to continuous improvement.

Qualifications

• Education: HBO (Higher Professional Education), depending on experience in similar roles.
• Quality System: Experience with quality systems and quality assurance in an operational environment, with proven knowledge of techniques for assessing process quality and the ability to guide others in these activities is desired.
• Projects: Participation in multidisciplinary projects with proven effective communication, teamwork, and problem-solving skills.
• Languages: Written and oral communication skills in Dutch and English.
• Systems: Excellent knowledge of personal computer systems and familiarity with MS Office.

JOB FAMILY: Operations Quality

DIVISION: ANSC Nutrition Supply Chain

LOCATION: Netherlands > Breda : Minervum 7201

WORK SHIFT: Standard

TRAVEL: Not specified

MEDICAL SURVEILLANCE: Not Applicable

SIGNIFICANT WORK ACTIVITIES: Not Applicable