Job Description

You\'re an important part of our future. Hopefully, we\'re also a part of yours! At B. Braun, we protect and improve the health of people worldwide. This is also our vision for research and development. You see complexity as an opportunity - and quality and sustainability are important criteria for your work. We would like to work with you on tomorrow\'s solutions. That\'s how we work to create sustainable healthcare - locally, in regions, countries and worldwide. Together. That\'s Sharing Expertise.Executive - ComplianceReference Code 202400135-86428Duties and responsibilities

• To be responsible and accountable for all aspects regarding compliance, complaints and CAPS, to ensure proper and smooth operations of the plant.
• To evaluate and monitor on plant\'s procedure /SOP/documentation/specification/records and to ensure they are in compliance with daily practice/operation of the assigned plant.
• To propose and to implement Corrective Action needed to align the compliance of plant practice and documentation.
• To ensure GMP compliance to regulatory requirements such as FDA/TUV.
• To coordinate necessary activites within the plant before, during and after the audits , internal and external.
• To coordinate all corrective actions needed after audits and to ensure timely response and implementation of corrective actions.
• To coordinate all CAPAs activites within the department and to ensure that al CAPAs are closed timely.
• To coordinate and monitor market complaints and to ensure timely feedfack/closure.
• To propose and implement necessary corrective actions related to market complaints, conduct internal audits within own division from time to time and to monitor/update on CAPA/market complaints during plant\'s regular meetings.
• The job function listed is not exhaustive and shall also include any responsibilities as assigned by the Supervisor from time to time.

Professional competencies

• Bachelor Degree in Engineering / Science or equivalent
• 1-2 years working experiences in quality /compliance /regulatory affair.
• Knowledge of Quality Management Systems related to Medical Devices, eg.: ISO13485, MDSAP, 21 CFR Part 820, GMP.
• Knowledge of Corrective Action and Preventive Action (CAPA) processes and Root Cause Analysis (RCA).
• Quality auditing experience or exposure to quality audit environment.
• Plan and execute necessary activities within the plant before, during and after the audits, internal and external.
• Evaluate and monitor on plant\'s procedure /SOP/documentation/specification/records and to ensure they are in compliance with daily practice/operation.
• Preferably in experience in driving continuous improvement in Quality / Compliance project with strong communication, coordination and follow-up skills.
• Preferably good statistical analysis skills and familiarity with tools (Pie chart, Histogram, Power BI etc)

Personal competencies

• Be accountable.
• Communicate effectively.
• Execute efficiently.

What we offerBecome part of a corporate culture that actively promotes constructive exchanges between colleagues, customers and partners. Work with us to improve people\'s lives in the long term. We can offer you interesting, varied tasks and excellent opportunities for advancement, as well as an attractive salary with extensive benefits, all within a dynamic family-owned company.Closing date2024-05-31

B. Braun