Faites partie de quelque chose de plus grand chez BD. Ici, vous nous aiderez à améliorer continuellement la façon dont nous faisons les choses chaque jour ; pour être plus efficace, plus performant et mieux servir nos clients. Vous ferez cela au sein d'une équipe exceptionnelle qui s'efforce de s'assurer que tout ce que nous faisons est conforme aux réglementations et aux normes, non seulement parce que c'est la bonne chose à faire, mais aussi parce que nos produits ont un impact sur la qualité de vie des gens. Ici, vous mettrez votre expérience en matière de conformité, vos attentes élevées et votre souci du détail au service du meilleur : faire progresser le monde de la santé™. Chez BD, vous pouvez faire une véritable différence d'une personne.
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Job Type:
Full-Time -
Job Level:
Entry to Senior -
Travel:
Varies -
Salary:
Competitive -
Responsibilities
Job Description Summary
The Quality System Leader is responsible for overseeing and maintaining the Quality Management System (QMS) to ensure compliance with medical device regulations and standards, with the leadership of the Quality System team. This role involves leading quality assurance initiatives, managing quality documentation, and ensuring that all processes meet the required quality standards.Job Description
Key Responsibilities:
Quality Management System (QMS) Implementation and Maintenance:
- Maintain quality management systems at the plant, based on ISO 13485 and related corporate standards
- Ensure compliance with EU MDR, FDA 21 CFR Part 820, and other relevant regulations
- Develop and maintain quality processes and documentation
- Act as the primary quality representative for regulatory audits and inspections
- Ensure accurate and timely reporting of quality metrics and initiatives
Quality Assurance:
- Responsible for internal and external quality audits. Prepares and organize external audits. Ensure each key contributor is available and prepared
- Oversee process for corrective and preventive actions (CAPA) and ensure the timely and appropriate execution
- Ownership at change control process
Training and Coaching:
- Train and coach associates on QMS processes and regulatory requirements
- Ensure that employees are compliant with quality standards through regular training sessions
Collaboration and Communication:
- Work closely with cross-functional teams, including internal (Production, Training/CI team, Engineering) and external (WW Quality System, Regulatory Affairs)
- Collaborate with external providers and suppliers to ensure quality standards are me
- Report to management on quality issues, trends, and effectiveness
Qualifications:
Education:
- BS/MS in Engineering or a relevant Life Science discipline
Experience:
- 5+ years of experience in a similar position
- 10+ years of experience in manufacturing environment within automotive-, electrical- or medical device industry
- Experience in quality auditing (hosting and executing)
Skills:
- Fluent in Hungarian and English
- Expertise in implementing and maintaining Quality Management Systems (QMS)
- Strong leadership skills to guide and motivate QS team and other cross-functional teams
- Excellent communication skills for effective collaboration and reporting
- Strong analytical skills to identify and resolve quality issues
- Proficiency in data analysis and quality metrics reporting
- Ability to work effectively in a team
- GMP and ISO 13485 knowledge is nice to have
Additional Requirements:
- Ability to work in a fast-paced and dynamic environment
- Ability to manage multiple projects and prioritize tasks effectively
Required Skills
Optional Skills
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Primary Work Location
HUN Kornye - UveggyarAdditional Locations
Work Shift
Success Profile
What makes a successful Quality Professional at BD? Check out the top traits we’re looking for and see if you have the right mix.
- Ambitious
- Collaborative
- Goal-oriented
- Persuasive
- Results-driven
- Self-starter
Advancing the world of health™
BD is one of the largest global medical technology companies in the world and is advancing the world of health™ by improving medical discovery, diagnostics and the delivery of care. BD helps customers enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care.